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
137d
Avg (2y)
1976
Since
7712 General & Plastic Surgery devices
5026–5050 of 7712
Cleared Oct 08, 1996
ARTHROCARE ARTHROSCOPIC ELETROSURGERY SYSTEM (MODEL 980)
K963123 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 57d
Cleared Oct 08, 1996
DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL
K961647 · Deroyal Industries, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 161d
Cleared Oct 03, 1996
IMPLANTECH JEJ PERI-PYRIFORM IMPLANT
K962824 · Implantech Associates, Inc.
FZE · Prosthesis, Nose, Internal · 76d
Cleared Sep 27, 1996
MENTOR INJECTION PORT DETECTOR (IPD)
K963066 · Mentor Corp.
LCJ · Tissue Expander And Accessories · 51d
Cleared Sep 25, 1996
AUTO SUTURE SURGIWAND
K961771 · United States Surgical, A Division of Tyco Healthc
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 140d
Cleared Sep 23, 1996
OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS
K962592 · Alcon Laboratories
GEX · Powered Laser Surgical Instrument · 83d
Cleared Sep 23, 1996
AUTO SUTURE MODIFIED VCS CLIP APPLIER
K962043 · United States Surgical, A Division of Tyco Healthc
FZP · Clip, Implantable · 118d
Cleared Sep 20, 1996
SIGNALDRESS
K962590 · Convatec, A Division of E.R. Squibb & Sons
FRO · Dressing, Wound, Drug · 80d
Cleared Sep 16, 1996
POLYPROPYLENE MESH (VARIOUS SIZES)
K962971 · Davis & Geck, Inc.
FTL · Mesh, Surgical, Polymeric · 47d
Cleared Sep 13, 1996
SHEATH, ELECTROSURGICAL PENCIL
K963088 · Aspen Laboratories, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 36d
Cleared Sep 11, 1996
ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP
K962258 · Ethicon Endo-Surgery, Inc.
GAG · Stapler, Surgical · 91d
Cleared Sep 11, 1996
AIRLIFT BALLOON RETRACTON SYSTEM
K962104 · Origin Medsystems, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 104d
Cleared Sep 03, 1996
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K962401 · W.L. Gore & Associates, Inc.
FTL · Mesh, Surgical, Polymeric · 74d
Cleared Aug 30, 1996
VALLEYLAB COATED ELECTRODES
K962044 · Valleylab, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 94d
Cleared Aug 22, 1996
MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT
K962013 · Mentor Corp.
MDA · Elastomer, Silicone, For Scar Management · 91d
Cleared Aug 22, 1996
STRYKER KNIFELIGHT
K961122 · Stryker Instruments
FTD · Lamp, Surgical · 154d
Cleared Aug 22, 1996
KARL STORZ INST. FOR ENDOSCOPIC SELECTIVE PERF. VEIN DISCISSION & PARATIBIAL FASCIOTOMY
K960903 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 170d
Cleared Aug 21, 1996
SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713)
K962974 · Sharplan Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 21d
Cleared Aug 19, 1996
IMPLANTECH WM NASAL-LABIAL IMPLANT
K962261 · Implantech Associates, Inc.
LZK · Implant, Malar · 68d
Cleared Aug 12, 1996
EXTRAHAND BALLOON RETRACTOR
K962005 · Origin Medsystems, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 82d
Cleared Aug 09, 1996
PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH
K962530 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 42d
Cleared Aug 02, 1996
COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED
K962480 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 37d
Cleared Jul 24, 1996
MEDLINE TITANIUM HEMOCLIPS
K962016 · Medline Industries, Inc.
FZP · Clip, Implantable · 62d
Cleared Jul 19, 1996
MD TECH BIOPSY SET FOR BONE AND BONE MARROW
K961959 · Medical Device Technologies, Inc.
GAA · Needle, Aspiration And Injection, Disposable · 60d
Cleared Jul 19, 1996
ENDOPATH EZ-RF LINEAR CUTTER AND COAGULATION
K961264 · Ethicon Endo-Surgery, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 108d

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All categories 7712 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1108 GCJ Laparoscope, General & Plastic Surgery 682 FRO Dressing, Wound, Drug 222 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 106 FZP Clip, Implantable 101 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