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

18201
Total
18157
Cleared
138d
Avg (2y)
1976
Since
4045 General & Plastic Surgery devices
2226–2250 of 4045
Cleared Nov 24, 2020
RF Surgical Generator
K200931 · Fulwell, LLC
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 231d
Cleared Nov 23, 2020
Mirus Ligating Clip, Mirus Ligating Clip Applier
K200166 · M/s. Meril Endo Surgery Private Limited.
FZP · Clip, Implantable · 306d
Cleared Nov 20, 2020
Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft
K202962 · New Deantronics Taiwan , Ltd.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 51d
Cleared Nov 20, 2020
Silatrix Oral Gel
K202000 · Sa3, LLC
OLR · Oral Wound Dressing · 123d
Cleared Nov 19, 2020
Laser Therapy Device
K202980 · Shenzhen Leaflife Technology Co., Ltd.
GEX · Powered Laser Surgical Instrument · 50d
Cleared Nov 19, 2020
Carewear Firefly Wrinkle Reduction
K202442 · Carewear Corp.
OHS · Light Based Over The Counter Wrinkle Reduction · 85d
Cleared Nov 19, 2020
StarWalker
K202172 · Fotona D.O.O.
GEX · Powered Laser Surgical Instrument · 108d
Cleared Nov 19, 2020
K2 MOBILE
K200693 · Hulaser, Inc.
GEX · Powered Laser Surgical Instrument · 248d
Cleared Nov 18, 2020
Chrome
K202503 · Quanta System Spa
GEX · Powered Laser Surgical Instrument · 79d
Cleared Nov 18, 2020
Viveve System
K200472 · Viveve Medical, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 266d
Cleared Nov 17, 2020
Disposable Trocar
K202931 · Wuxi Shukang Medical Appliance Co., Ltd.
GCJ · Laparoscope, General & Plastic Surgery · 49d
Cleared Nov 16, 2020
Nd: YAG Laser Therapy Systems HM-YL900
K202758 · Shangdong Huamei Technology Co., Ltd.
GEX · Powered Laser Surgical Instrument · 56d
Cleared Nov 16, 2020
Sientra OPUS Silicone Gel Breast Implant Sizer
K200706 · Sientra, Inc.
MRD · Mammary Sizer · 243d
Cleared Nov 13, 2020
NEUWAVE Microwave Ablation System and Accessories
K200081 · Neuwave Medical, Inc.
NEY · System, Ablation, Microwave And Accessories · 303d
Cleared Nov 12, 2020
da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories
K202571 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 69d
Cleared Nov 10, 2020
SnapshotNIR
K201976 · Kent Imaging
MUD · Oximeter, Tissue Saturation · 117d
Cleared Nov 06, 2020
Medical RF
K192621 · Triworks Group Srl
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 410d
Cleared Nov 05, 2020
SPY-PHI System with SPY-PHI Fluorescence Assessment Software
K202244 · Novadaq Technologies Ulc. (Now A Part of Stryker)
OWN · Confocal Optical Imaging · 87d
Cleared Nov 03, 2020
Palm NRG cellulite and muscle toning body device
K191940 · Heat IN A Click
PBX · Massager, Vacuum, Radio Frequency Induced Heat · 473d
Cleared Nov 02, 2020
IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle
K203032 · Galil Medical, Inc.
GEH · Unit, Cryosurgical, Accessories · 28d
Cleared Nov 02, 2020
Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set
K202562 · Ellusa, LLC
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 59d
Cleared Nov 02, 2020
Ellusa Bipolar Wands
K202558 · Ellusa, LLC
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 59d
Cleared Oct 30, 2020
Aesculap Caiman 5 Seal and Cut Technology System
K202938 · Aesculap, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 30d
Cleared Oct 30, 2020
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack
K202157 · Smith & Nephew Medical Limited
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 88d
Cleared Oct 28, 2020
Tri-Staple 2.0 Reloads
K202864 · Covidien
GDW · Staple, Implantable · 30d

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All categories 4045 GEI Electrosurgical, Cutting & Coagulation & Accessories 539 GEX Powered Laser Surgical Instrument 497 GCJ Laparoscope, General & Plastic Surgery 330 FRO Dressing, Wound, Drug 163 OHT Light Based Over-the-counter Hair Removal 142 OHS Light Based Over The Counter Wrinkle Reduction 118 GDW Staple, Implantable 101 NAY System, Surgical, Computer Controlled Instrument 99 FTL Mesh, Surgical, Polymeric 94 OMP Negative Pressure Wound Therapy Powered Suction Pump 93 KGN Wound Dressing With Animal-derived Material(s) 74 OAP Laser, Comb, Hair 72 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 71 GAM Suture, Absorbable, Synthetic, Polyglycolic Acid 62 GEH Unit, Cryosurgical, Accessories 62