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

18327
Total
18282
Cleared
139d
Avg (2y)
1976
Since
14319 General & Plastic Surgery devices
14001–14025 of 14319
Cleared Nov 16, 1979
HYDRON BURN DRESSING FIELD KIT
K791865 · National Patent Development Corp.
KMF · Bandage, Liquid · 56d
Cleared Nov 16, 1979
SAFE RETURN COT. #9675 & CONNECTOR ADAPT
K792044 · Concept, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 35d
Cleared Nov 16, 1979
HAAG-STREIT SLIT LAMP 900
K792083 · Lumenis, Inc.
HRM · Microscope, Operating & Accessories, Ac-powered, Ophthalmic · 31d
Cleared Nov 16, 1979
HYPO-ALLERGENIC CLOTH ADHESIVE TAPE
K792102 · National Patent Development Corp.
KGX · Tape And Bandage, Adhesive · 28d
Cleared Nov 16, 1979
HYPO-ALLERGENIC PAPER ADHESIVE TAPE
K792103 · National Patent Development Corp.
KGX · Tape And Bandage, Adhesive · 28d
Cleared Nov 13, 1979
GAVAGE FEEDING SET
K792082 · Medical Devices, Inc.
EYN · Tray, Irrigation, Sterile · 28d
Cleared Nov 05, 1979
HEWSON LIGAMENT BUTTON
K792004 · Richard'S Medical Equip., Inc.
KGS · Retention Device, Suture · 33d
Cleared Nov 05, 1979
CONPHAR O.R. HEAD COVER-STERILE
K792106 · Conphar, Inc.
FYI · Appliance, Facial Fracture, External · 11d
Cleared Oct 22, 1979
EMS ADAPTER MODEL 9160
K791541 · Concept, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 73d
Cleared Oct 17, 1979
BAYONET HEIFETZ CLIP APPLIERS
K791845 · Edward Weck, Inc.
GDO · Applier, Surgical, Clip · 28d
Cleared Oct 17, 1979
HAND TOWEL
K791926 · Procter & Gamble Mfg. Co.
NAB · Gauze / Sponge,nonresorbable For External Use · 20d
Cleared Oct 17, 1979
DEXIDE DISPOSABLE SURGICAL SCRUB BRUSH
K791949 · Dexide, Inc.
GEC · Brush, Scrub, Operating-room · 16d
Cleared Oct 17, 1979
DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE
K791950 · Dexide, Inc.
GEC · Brush, Scrub, Operating-room · 16d
Cleared Oct 17, 1979
DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE
K791951 · Dexide, Inc.
GEC · Brush, Scrub, Operating-room · 16d
Cleared Oct 17, 1979
DEXIDE DISPOSABLE SURGICAL SCRUB BRUSH
K791952 · Dexide, Inc.
GEC · Brush, Scrub, Operating-room · 16d
Cleared Oct 17, 1979
SCISSOR'S #'S 2294,2262,2263
K791984 · Edward Weck, Inc.
FZT · Cutter, Surgical · 22d
Cleared Oct 11, 1979
BOVIE CSV HAND CONTROL ADAPTER
K791767 · Sybron Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 36d
Cleared Oct 04, 1979
TEW BYPASS INSTRUMENTS & DISSECTING KIT
K791703 · Edward Weck, Inc.
GDI · Dissector, Surgical, General & Plastic Surgery · 37d
Cleared Oct 04, 1979
FLOOR LINE INSTRUMENTS
K791741 · Edward Weck, Inc.
FZT · Cutter, Surgical · 24d
Cleared Oct 04, 1979
BROOKS GALL BLADDER SCISSORS (SURG)
K791742 · Edward Weck, Inc.
FZT · Cutter, Surgical · 24d
Cleared Oct 04, 1979
LECTROVAC, VALLEYLAB MODELS
K791752 · Valleylab, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 29d
Cleared Oct 04, 1979
TEST PRESSURE GAUGE #6675-32
K791759 · Depuy, Inc.
KCY · Tourniquet, Pneumatic · 29d
Cleared Oct 04, 1979
TECNOL STIRRUPS STRAP
K791859 · Tecnol New Jersey Wound Care, Inc.
BWN · Table And Attachments, Operating-room · 16d
Cleared Oct 04, 1979
VASCULAR FORCEPS & CLAMPS
K791987 · Edward Weck, Inc.
GEN · Forceps, General & Plastic Surgery · 9d
Cleared Sep 27, 1979
SPREADER
K781445 · Orthopedic Equipment Co., Inc.
GAD · Retractor · 400d

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All categories 14319 GEX Powered Laser Surgical Instrument 2429 GEI Electrosurgical, Cutting & Coagulation & Accessories 1933 GCJ Laparoscope, General & Plastic Surgery 1130 FRO Dressing, Wound, Drug 591 FTL Mesh, Surgical, Polymeric 324 GDW Staple, Implantable 267 GEH Unit, Cryosurgical, Accessories 216 OMP Negative Pressure Wound Therapy Powered Suction Pump 214 KGN Wound Dressing With Animal-derived Material(s) 177 OHT Light Based Over-the-counter Hair Removal 166 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 164 NAY System, Surgical, Computer Controlled Instrument 164 OHS Light Based Over The Counter Wrinkle Reduction 161 KMF Bandage, Liquid 157 EFQ Gauze/sponge, Internal 157