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
14154 General & Plastic Surgery devices
10426–10450 of 14154
Cleared Dec 27, 1994
PERSONAL HEARING SYSTEM
K944041 · Resound Corp.
LRS · I.v. Start Kit · 131d
Cleared Dec 27, 1994
SUNRISE TECHNOLOGIES MODEL 5020 PLDD KIT
K944758 · Cardiogenes
GEX · Powered Laser Surgical Instrument · 95d
Cleared Dec 22, 1994
OPTICA 100 SUPERPULSED LASER SYSTEM
K944749 · Xintec Corporation
GEX · Powered Laser Surgical Instrument · 87d
Cleared Dec 21, 1994
ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIES
K943055 · Megadyne Medical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 177d
Cleared Dec 21, 1994
ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR
K944012 · Aspen Laboratories, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 127d
Cleared Dec 21, 1994
EVERSHEARS(R) SCISSORS, BILAP(R) PROBES, BICOAG(R) FORCEPS
K945975 · Everest Medical Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 13d
Cleared Dec 20, 1994
KARL STORZ TELESCOPE BRIDGES AND ADAPTERS
K946023 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 11d
Cleared Dec 19, 1994
OREX
K940716 · Thantex Specialties, Inc.
EFQ · Gauze/sponge, Internal · 304d
Cleared Dec 19, 1994
OREX
K940764 · Thantex Specialties, Inc.
GDY · Gauze/sponge, Internal, X-ray Detectable · 304d
Cleared Dec 19, 1994
ISOLYSER
K940765 · Thantex Specialties, Inc.
EFQ · Gauze/sponge, Internal · 304d
Cleared Dec 19, 1994
OREX (18X18 X-RAY DETECTABLE)
K940766 · Thantex Specialties, Inc.
GDY · Gauze/sponge, Internal, X-ray Detectable · 304d
Cleared Dec 19, 1994
OREX (12X12 X-RAY DETECTABLE)
K940767 · Thantex Specialties, Inc.
GDY · Gauze/sponge, Internal, X-ray Detectable · 304d
Cleared Dec 19, 1994
ACUTOME 100 COLOR-CORRECTED CO2 LASER HANDPIECE
K942935 · Reliant Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 180d
Cleared Dec 15, 1994
L-CATH CONNECTOR ASSEMBLY
K940198 · Luther Medical Products, Inc.
GCD · Connector, Catheter · 336d
Cleared Dec 15, 1994
OPTILITE V FIBEROPTIC ACCESSORIES
K944474 · Xintec Corporation
GEX · Powered Laser Surgical Instrument · 97d
Cleared Dec 15, 1994
KARL STORZ TROCARD, FLEXIBLE TROCAR SLEEVES
K945751 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 22d
Cleared Dec 13, 1994
UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED
K943045 · Reliant Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 169d
Cleared Dec 13, 1994
DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE
K945893 · Boston Surgical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 11d
Cleared Dec 13, 1994
ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES
K945898 · Megadyne Medical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 11d
Cleared Dec 08, 1994
KARL STORZ INSULATED BIOPSY FORCEPS
K944299 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 93d
Cleared Dec 08, 1994
BIPOLAR CORD
K944578 · Boston Surgical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 80d
Cleared Dec 08, 1994
ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
K944634 · Boston Surgical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 78d
Cleared Dec 08, 1994
ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
K944642 · Boston Surgical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 78d
Cleared Dec 08, 1994
TRELEX NATURAL(R) MESH
K945377 · Meadox Medicals, Div. Boston Scientific Corp.
FTL · Mesh, Surgical, Polymeric · 45d
Cleared Dec 08, 1994
CANDELA ELLIPTICAL SPOT HANDPIECE
K945587 · Candela Laser Corp.
GEX · Powered Laser Surgical Instrument · 24d

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All categories 14154 GEX Powered Laser Surgical Instrument 2391 GEI Electrosurgical, Cutting & Coagulation & Accessories 1898 GCJ Laparoscope, General & Plastic Surgery 1122 FRO Dressing, Wound, Drug 584 FTL Mesh, Surgical, Polymeric 317 GDW Staple, Implantable 262 GEH Unit, Cryosurgical, Accessories 214 OMP Negative Pressure Wound Therapy Powered Suction Pump 213 KGN Wound Dressing With Animal-derived Material(s) 174 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 163 OHS Light Based Over The Counter Wrinkle Reduction 161 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 160 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 155