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

18256
Total
18211
Cleared
136d
Avg (2y)
1976
Since
7629 General & Plastic Surgery devices
3201–3225 of 7629
Cleared Oct 23, 2017
Monosyn Quick Synthetic Absorbable Surgical Suture
K171001 · Aesculap, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 202d
Cleared Oct 19, 2017
Discovery Pico, Discovery Pico Plus
K172376 · Quanta System Spa
GEX · Powered Laser Surgical Instrument · 73d
Cleared Oct 18, 2017
ANCHOR Tissue Retrieval System
K172940 · Conmed Corporation
GCJ · Laparoscope, General & Plastic Surgery · 22d
Cleared Oct 17, 2017
585
K172198 · Quanta System Spa
GEX · Powered Laser Surgical Instrument · 88d
Cleared Oct 11, 2017
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)
K172742 · AtriCure, Inc.
FZP · Clip, Implantable · 29d
Cleared Oct 05, 2017
PROLENE Soft Polypropylene Mesh
K172089 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 86d
Cleared Oct 04, 2017
Ultrasonic Generator
K172691 · Olympus Medical Systems Corp.
LFL · Instrument, Ultrasonic Surgical · 28d
Cleared Oct 04, 2017
HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal
K172671 · Conmed Corporation
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 29d
Cleared Sep 28, 2017
CUSA Excel+ Ultrasonic Surgical Aspirator System
K172595 · Integra LifeSciences Corporation
LFL · Instrument, Ultrasonic Surgical · 30d
Cleared Sep 26, 2017
SculpSure
K171992 · Cynosure, Inc.
PKT · Laser For Disruption Of Adipocyte Cells For Aesthetic Use · 85d
Cleared Sep 22, 2017
TempSure
K171262 · Cynosure, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 144d
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 19, 2017
da Vinci Xi Surgical System
K171632 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 109d
Cleared Sep 12, 2017
da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories
K170875 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 172d
Cleared Sep 11, 2017
da Vinci Xi EndoWrist Instruments and Accessories
K170645 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 193d
Cleared Sep 11, 2017
da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)
K170644 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 193d
Cleared Aug 24, 2017
VenaCure EVLT NeverTouch Procedure Kit
K171921 · AngioDynamics, Inc.
GEX · Powered Laser Surgical Instrument · 58d
Cleared Aug 22, 2017
Stryker Integrated Bipolar Cord and Tubing Sets
K172367 · Stryker Instruments
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 18d
Cleared Aug 22, 2017
GRAVITY™ Soft Tissue Repair System
K170642 · Wrightmedicaltechnologyinc
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 173d
Cleared Aug 17, 2017
DeRoyal Laprador Specimen Retrieval System
K171475 · Deroyal Industries, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 90d
Cleared Aug 02, 2017
AUTOCON III 400
K171717 · KARL STORZ Endoscopy-America, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 54d
Cleared Jul 31, 2017
Litho 60
K172025 · Quanta System Spa
GEX · Powered Laser Surgical Instrument · 26d
Cleared Jul 28, 2017
Discovery Pico, Discovery Pico Plus
K171945 · Quanta System Spa
GEX · Powered Laser Surgical Instrument · 30d
Cleared Jul 28, 2017
da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System
K171699 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 50d

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All categories 7629 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1105 GCJ Laparoscope, General & Plastic Surgery 680 FRO Dressing, Wound, Drug 214 FTL Mesh, Surgical, Polymeric 186 GDW Staple, Implantable 159 NAY System, Surgical, Computer Controlled Instrument 158 OHT Light Based Over-the-counter Hair Removal 142 OHS Light Based Over The Counter Wrinkle Reduction 120 OMP Negative Pressure Wound Therapy Powered Suction Pump 101 FZP Clip, Implantable 98 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 93 KGN Wound Dressing With Animal-derived Material(s) 85 LFL Instrument, Ultrasonic Surgical 85 GEH Unit, Cryosurgical, Accessories 78