FDA Review Panel · SU

FDA 510(k) General & Plastic Surgery Devices

About General & Plastic Surgery Devices

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

18146
Total
18103
Cleared
114d
Avg days
1976
Since
1338 General & Plastic Surgery devices
1276–1300 of 1338
Cleared Jan 05, 2022
BTL-899A
K213344 · BTL Industries, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 90d
Cleared Jan 05, 2022
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
K211318 · Smith & Nephew Medical Limited
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 250d
Cleared Jan 05, 2022
Urethral Warming Catheter Kit
K211149 · Varian Medical Systems, Inc.
GEH · Unit, Cryosurgical, Accessories · 261d
Cleared Jan 04, 2022
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
K213831 · Gyrus Acmi, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 27d
Cleared Dec 17, 2021
Single Use Electrosurgical Knife with Fluid Pump System
K211172 · Micro-Tech (Nanjing) Co., Ltd.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 242d
Cleared Dec 16, 2021
Connected OR Hub with Device and Voice Control
K212055 · Stryker Corporation
GCJ · Laparoscope, General & Plastic Surgery · 168d
Cleared Dec 10, 2021
8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads
K211997 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 165d
Cleared Dec 07, 2021
DERMABOND PRINEO Skin Closure System
K213512 · Ethicon, Inc.
OMD · Cutaneous Tissue Adhesive With Mesh · 35d
Cleared Dec 03, 2021
Solero Microwave Tissue Ablation (MTA) System and Accessories
K213067 · AngioDynamics, Inc.
NEY · System, Ablation, Microwave And Accessories · 71d
Cleared Dec 03, 2021
Medline Cardiovascular Procedure Kit
K212258 · Medline Industries, Inc.
LRO · General Surgery Tray · 136d
Cleared Nov 29, 2021
C2 CryoBalloon Ablation System
K212814 · Pentax of America, Inc.
GEH · Unit, Cryosurgical, Accessories · 87d
Cleared Nov 23, 2021
da Vinci SP Firefly Imaging System
K212101 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 140d
Cleared Nov 19, 2021
Arthrex Vortex Threaded Bone Marrow Recovery Needle
K213213 · Arthrex, Inc.
KNW · Instrument, Biopsy · 51d
Cleared Nov 15, 2021
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
K212301 · Covidien, LLC
LFL · Instrument, Ultrasonic Surgical · 115d
Cleared Nov 04, 2021
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)
K212511 · Stryker
GCJ · Laparoscope, General & Plastic Surgery · 86d
Cleared Oct 25, 2021
Arthrex LoopLoc Knotless Suture
K212146 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 108d
Cleared Oct 21, 2021
DEKA LipoAI
K212270 · El.En Electronic Engineering Spa
GEX · Powered Laser Surgical Instrument · 93d
Cleared Oct 19, 2021
AcuPulse CO2 Laser System, Delivery Devices and Accessories
K212703 · Lumenis, Ltd.
GEX · Powered Laser Surgical Instrument · 54d
Cleared Oct 15, 2021
Deka Tiac II
K211091 · El.En Electronic Engineering Spa
PBX · Massager, Vacuum, Radio Frequency Induced Heat · 186d
Cleared Oct 08, 2021
INTEGRA Wound Matrix (Macro-Channels)
K210128 · Integra LifeSciences Corporation
KGN · Wound Dressing With Animal-derived Material(s) · 262d
Cleared Sep 29, 2021
Da Vinci SP Surgical System
K212747 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 30d
Cleared Aug 25, 2021
SCAR 3
K211362 · El.En Electronic Engineering Spa
GEX · Powered Laser Surgical Instrument · 114d
Cleared Aug 12, 2021
Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles
K210946 · Promisemed Hangzhou Meditech Co., Ltd.
KNW · Instrument, Biopsy · 135d
Cleared Aug 06, 2021
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
K211784 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 58d
Cleared Aug 04, 2021
Ultrasonic Bipolar Generator USG-410 with accessories
K211838 · Olympus Medical Systems Corporation
LFL · Instrument, Ultrasonic Surgical · 51d

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All categories 1338 GEX Powered Laser Surgical Instrument 220 GEI Electrosurgical, Cutting & Coagulation & Accessories 177 GCJ Laparoscope, General & Plastic Surgery 91 OHS Light Based Over The Counter Wrinkle Reduction 72 OHT Light Based Over-the-counter Hair Removal 65 FRO Dressing, Wound, Drug 57 NAY System, Surgical, Computer Controlled Instrument 46 KGN Wound Dressing With Animal-derived Material(s) 36 GEH Unit, Cryosurgical, Accessories 30 FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 25 OMP Negative Pressure Wound Therapy Powered Suction Pump 23 KNW Instrument, Biopsy 21 OAP Laser, Comb, Hair 21 PBX Massager, Vacuum, Radio Frequency Induced Heat 20 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 18