FDA Review Panel · SU

FDA 510(k) General & Plastic Surgery Devices

FDA 510(k) General & Plastic Surgery Devices - Regulatory Overview

FDA 510(k) general and plastic surgery devices represent the largest 510(k) category with 18,104 submissions since 1976. The FDA review panel code is SU.

This panel covers a broad range of surgical equipment:

  • Electrosurgical units (ESU) - monopolar and bipolar cutting and coagulation
  • Surgical lasers - CO2, Nd:YAG, diode and excimer surgical lasers
  • Laparoscopic instruments - trocars, graspers, staplers, clip appliers
  • Wound care and closure - negative pressure therapy, staples, tissue adhesives
  • Aesthetic devices - body contouring, skin resurfacing, fat reduction systems

18288
Total
18243
Cleared
138d
Avg (2y)
1976
Since
13639 General & Plastic Surgery devices
3351–3375 of 13639
Cleared Oct 03, 2017
Force Fiber Fusion Suture
K172016 · Teleflex Medical Incorporated
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 92d
Cleared Oct 02, 2017
iSurg
K170054 · Jaco, LLC Dba Macan Manufacturing and Bna Burz North America
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 269d
Cleared Sep 29, 2017
CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture
K170166 · Cpt Sutures Co., Ltd.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 253d
Cleared Sep 28, 2017
MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture
K172659 · M/s. Meril Endo Surgery Private Limited.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 23d
Cleared Sep 28, 2017
CUSA Excel+ Ultrasonic Surgical Aspirator System
K172595 · Integra LifeSciences Corporation
LFL · Instrument, Ultrasonic Surgical · 30d
Cleared Sep 28, 2017
Single Use Micro Electrode (Brass with gold plated shaft)
K163442 · Modern Medical Equipment Manufacturing Limited
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 294d
Cleared Sep 28, 2017
Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)
K161434 · Li-Tek Electronics Technologies
OLP · Over-the-counter Powered Light Based Laser For Acne · 492d
Cleared Sep 27, 2017
CRYOFOS
K170810 · Cryofos Medical GmbH
GEH · Unit, Cryosurgical, Accessories · 194d
Cleared Sep 26, 2017
SculpSure
K171992 · Cynosure, Inc.
PKT · Laser For Disruption Of Adipocyte Cells For Aesthetic Use · 85d
Cleared Sep 25, 2017
LapBag
K171726 · Sejong Medical Co., Ltd.
GCJ · Laparoscope, General & Plastic Surgery · 105d
Cleared Sep 25, 2017
Exofin Fusion Skin Closure System
K171442 · Chemence Medical, Inc.
OMD · Cutaneous Tissue Adhesive With Mesh · 132d
Cleared Sep 22, 2017
SERI Contour
K172545 · Sofregen Medical, Inc.
OXF · Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery · 30d
Cleared Sep 22, 2017
Sterling Supreme Diode Laser
K171986 · CAO Group, Inc.
GEX · Powered Laser Surgical Instrument · 81d
Cleared Sep 22, 2017
Occlusion Detection Dressing Kit
K171499 · Cardinalhealth
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 122d
Cleared Sep 22, 2017
TempSure
K171262 · Cynosure, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 144d
Cleared Sep 22, 2017
Thermage FLX System and Accessories
K170758 · Solta Medical
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 193d
Cleared Sep 21, 2017
Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle
K172486 · Anexa Biomedical, Inc.
FRO · Dressing, Wound, Drug · 35d
Cleared Sep 21, 2017
IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories
K170879 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 181d
Cleared Sep 21, 2017
da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes
K170641 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 203d
Cleared Sep 20, 2017
PICO Single Use Negative Pressure Wound Therapy System
K172521 · Smith & Nephew Medical Limited
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 30d
Cleared Sep 19, 2017
da Vinci Xi Surgical System
K171632 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 109d
Cleared Sep 18, 2017
LightSheer Desire
K170179 · Lumenis, Ltd.
GEX · Powered Laser Surgical Instrument · 242d
Cleared Sep 18, 2017
Winback Back 3SE
K162828 · Winback USA Corp
PBX · Massager, Vacuum, Radio Frequency Induced Heat · 346d
Cleared Sep 15, 2017
PICO Single Use Negative Pressure Wound Therapy System
K172519 · Smith & Nephew Medical Limited
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 25d
Cleared Sep 14, 2017
IntelliCart System
K172481 · Dornoch Medical Systems
JCX · Apparatus, Suction, Ward Use, Portable, Ac-powered · 29d

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All categories 13639 GEX Powered Laser Surgical Instrument 2323 GEI Electrosurgical, Cutting & Coagulation & Accessories 1818 GCJ Laparoscope, General & Plastic Surgery 1080 FRO Dressing, Wound, Drug 521 FTL Mesh, Surgical, Polymeric 301 GDW Staple, Implantable 247 GEH Unit, Cryosurgical, Accessories 207 OMP Negative Pressure Wound Therapy Powered Suction Pump 205 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 KGN Wound Dressing With Animal-derived Material(s) 162 OHS Light Based Over The Counter Wrinkle Reduction 158 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 150 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 147