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
14008 General & Plastic Surgery devices
8101–8125 of 14008
Cleared Oct 11, 2001
CANDELA CLEARBEAM PULSED DYE LASER
K013043 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 31d
Cleared Oct 05, 2001
ZEUS ROBOTIC SURGICAL SYSTEM
K003431 · Computer Motion, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 336d
Cleared Oct 05, 2001
SOCRATES ROBOTIC TELEMONITORING SYSTEM
K003661 · Computer Motion, Inc.
NEQ · Device, Telemedicine, Robotic · 311d
Cleared Oct 04, 2001
MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS
K010804 · Biolitec, Inc.
GEX · Powered Laser Surgical Instrument · 202d
Cleared Oct 04, 2001
ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201
K012923 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 34d
Cleared Oct 04, 2001
MODIFICATION TO: THERMACOOL IIA
K013034 · Thermage, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 24d
Cleared Oct 03, 2001
BIPOLAR IRRIGATION FORCEPS
K012986 · Aesculap, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 27d
Cleared Oct 02, 2001
COOLTOUCH VARIZOOM
K012982 · New Star Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 27d
Cleared Oct 01, 2001
ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145
K012176 · Ethicon Endo-Surgery, Inc.
LFL · Instrument, Ultrasonic Surgical · 81d
Cleared Sep 25, 2001
EASY GUIDE ELECTROSURGICAL ACCESS DEVICE
K012004 · Senorx, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 90d
Cleared Sep 19, 2001
DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088
K011944 · Smith & Nephew, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 90d
Cleared Sep 19, 2001
PREMICRON NONABSORBABLE PET SURGICAL SUTURE
K012201 · Aesculap, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 68d
Cleared Sep 10, 2001
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
K011841 · Karl Storz Endoscopy
GCJ · Laparoscope, General & Plastic Surgery · 90d
Cleared Sep 07, 2001
CYNOSURE ACCLAIM DERMATOLOGY LASER
K011828 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 87d
Cleared Sep 06, 2001
LIVER TAMPONADE BALLOON
K010450 · Cook, Inc.
NGU · Balloon, Liver Tamponade · 203d
Cleared Sep 06, 2001
VERASTEP
K012539 · United States Surgical, A Division of Tyco Healthc
GCJ · Laparoscope, General & Plastic Surgery · 30d
Cleared Sep 05, 2001
AMS SOFT-TISSUE APPROXIMATION SYSTEM
K012342 · American Medical Systems, Inc.
FZP · Clip, Implantable · 43d
Cleared Sep 04, 2001
ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL
K012799 · Senorx, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 14d
Cleared Aug 30, 2001
ATRICURE BIPOLAR COAGULATION SYSTEM
K011722 · AtriCure, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 87d
Cleared Aug 30, 2001
PALOMAR LC 100 DIODE LASER
K011747 · Palomar Medical Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 86d
Cleared Aug 30, 2001
MODIFICATION TO:ENDIUS BIPOLAR SHEATH
K012488 · Endius, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 27d
Cleared Aug 22, 2001
RADIOGRAPHIC MARKERS
K011856 · Encore Orthopedics, Inc.
NEU · Marker, Radiographic, Implantable · 70d
Cleared Aug 22, 2001
ORTHO DEVELOPMENT ORION-I EMF SYSTEM
K012129 · Ortho Development Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 44d
Cleared Aug 09, 2001
ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM
K011538 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 83d
Cleared Aug 01, 2001
AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011372 · Aesculap, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 89d

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All categories 14008 GEX Powered Laser Surgical Instrument 2372 GEI Electrosurgical, Cutting & Coagulation & Accessories 1869 GCJ Laparoscope, General & Plastic Surgery 1113 FRO Dressing, Wound, Drug 572 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 257 OMP Negative Pressure Wound Therapy Powered Suction Pump 211 GEH Unit, Cryosurgical, Accessories 210 KGN Wound Dressing With Animal-derived Material(s) 171 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 159 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 157 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 155