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
7738 General & Plastic Surgery devices
6776–6800 of 7738
Cleared Sep 06, 1985
REUSABLE END CUTTERS IN 3.5 & 4.2MM CONFIGUATION
K853494 · Chattanooga Group, Inc.
· 17d
Cleared Sep 06, 1985
REUSABLE BULLET NOSE CUTTERS IN 3.5 & 4.2MM CONFIG
K853493 · Chattanooga Group, Inc.
· 17d
Cleared Sep 06, 1985
REUSABLE TRIMMER BLADES IN 3.5/4.2/5.5MM CONFIGUAT
K853492 · Chattanooga Group, Inc.
· 17d
Cleared Sep 06, 1985
REUSABLE DEXTRA SYNOVIAL RESECTORS IN 3.5/4.5/5.5M
K853491 · Chattanooga Group, Inc.
· 17d
Cleared Sep 06, 1985
REUSABLE ABRADER TIPS IN 3.5MM & 5.5MM CONFIGUATIO
K853490 · Chattanooga Group, Inc.
· 17d
Cleared Sep 06, 1985
NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428,
K851305 · Richards Medical Co., Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 158d
Cleared Sep 06, 1985
NON/GEL ADHESIVE DISPERSIVE ELECTRODE 3427,33-4270
K851304 · Richards Medical Co., Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 158d
Cleared Sep 05, 1985
REUSABLE JACOBS DRILL CHUCK
K853495 · Chattanooga Group, Inc.
· 16d
Cleared Sep 05, 1985
BAND-AID BRAND ADHESIVE BANDAGES
K852545 · Johnson & Johnson Professionals, Inc.
FRO · Dressing, Wound, Drug · 83d
Cleared Sep 03, 1985
SINGLE USE ARTHROSCOPY ELECTRODE
K852355 · Aspen Laboratories, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 92d
Cleared Aug 30, 1985
KENDALL CURITY BURN PAD
K853145 · The Kendal Co.
FPY · Sheet, Burn · 32d
Cleared Aug 21, 1985
STAPLE REMOVER
K853286 · I M, Inc.
· 16d
Cleared Aug 14, 1985
COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY
K851000 · Cooper Lasersonics, Inc.
GEX · Powered Laser Surgical Instrument · 156d
Cleared Aug 12, 1985
ELECTROSURGICAL LATERAL RELEASE PROBE MOD ALR-100
K852683 · American Bentley
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 48d
Cleared Aug 07, 1985
BONE RONGEURS
K852993 · The Huxley Instrument Corp.
· 23d
Cleared Jul 29, 1985
SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420
K853015 · The Huxley Instrument Corp.
GEN · Forceps, General & Plastic Surgery · 12d
Cleared Jul 26, 1985
SPINAL FIXATION INSTRUMENTATION SYSTEM
K852891 · Buckman Co., Inc.
· 17d
Cleared Jul 23, 1985
SUSZOI ULTRASONIC SURGICAL ASPIRATOR SONOP
K852539 · Johnson & Johnson Professionals, Inc.
LFL · Instrument, Ultrasonic Surgical · 39d
Cleared Jul 23, 1985
OPSITE WOUND DRESSING
K852211 · Smith & Nephew, Inc.
NAD · Dressing, Wound, Occlusive · 63d
Cleared Jul 23, 1985
R PAK
K851203 · CooperVision, Inc.
LFL · Instrument, Ultrasonic Surgical · 119d
Cleared Jul 15, 1985
SCALPEL HANDLE #7 SS 410 OR 420
K852735 · The Huxley Instrument Corp.
GDZ · Handle, Scalpel · 19d
Cleared Jul 15, 1985
O.R. SCISSORS, STRAIGHT, 5-1/2+SHP/SHP SS
K852734 · The Huxley Instrument Corp.
· 19d
Cleared Jul 15, 1985
IRIS SCISSORS, CURVED, 4-1/2+SS 410 OR 420
K852732 · The Huxley Instrument Corp.
· 19d
Cleared Jul 15, 1985
LISTER BANDAGE SCISSORS, 5-1/2+SS 410 OR 420
K852731 · The Huxley Instrument Corp.
· 19d
Cleared Jul 15, 1985
CRILE FORCEPS, STRIAGHT, 6-1/4+SS 410 OR 420
K852730 · The Huxley Instrument Corp.
GEN · Forceps, General & Plastic Surgery · 19d

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All categories 7738 GEX Powered Laser Surgical Instrument 1172 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 LFL Instrument, Ultrasonic Surgical 85 KGN Wound Dressing With Animal-derived Material(s) 85 GEH Unit, Cryosurgical, Accessories 78