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
7715 General & Plastic Surgery devices
6101–6125 of 7715
Cleared Jan 31, 1991
FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE
K905440 · United States Surgical, A Division of Tyco Healthc
GAS · Suture, Nonabsorbable, Synthetic, Polyester · 58d
Cleared Jan 31, 1991
FLOWERS JOWL IMPLANT
K905268 · Implantech Associates, Inc.
FWP · Prosthesis, Chin, Internal · 71d
Cleared Jan 31, 1991
FLOWERS CHIN IMPLANT
K905267 · Implantech Associates, Inc.
FWP · Prosthesis, Chin, Internal · 71d
Cleared Jan 31, 1991
AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER
K905106 · United States Surgical, A Division of Tyco Healthc
GDW · Staple, Implantable · 79d
Cleared Jan 29, 1991
AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER*
K904931 · United States Surgical, A Division of Tyco Healthc
GAR · Suture, Nonabsorbable, Synthetic, Polyamide · 90d
Cleared Jan 28, 1991
MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS
K901853 · Johnson & Johnson Medical, Inc.
NAD · Dressing, Wound, Occlusive · 279d
Cleared Jan 25, 1991
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
K904852 · Convatec, A Division of E.R. Squibb & Sons
FRO · Dressing, Wound, Drug · 88d
Cleared Jan 24, 1991
PARK CITY SHOULDER POSITIONER
K910031 · Orthopedic Systems, Inc.
FWZ · Operating Room Accessories Table Tray · 20d
Cleared Jan 18, 1991
ILLUMINA MODEL 780 CO2 LASER SYSTEM
K905637 · Heraeus Lasersonics, Inc.
GEX · Powered Laser Surgical Instrument · 32d
Cleared Jan 17, 1991
AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP
K905379 · United States Surgical, A Division of Tyco Healthc
GAR · Suture, Nonabsorbable, Synthetic, Polyamide · 48d
Cleared Jan 16, 1991
AUTO SUTURE(R) ENDOSCOPIC LDS(TM) LIGATING DEVICE
K905587 · United States Surgical, A Division of Tyco Healthc
FZP · Clip, Implantable · 34d
Cleared Jan 04, 1991
ELECTROSURGICAL PENCIL
K904808 · Megadyne Medical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 72d
Cleared Dec 31, 1990
NONABSORBABLE POLYPROPYLENE SURGICAL MESH
K905655 · United States Surgical, A Division of Tyco Healthc
FTL · Mesh, Surgical, Polymeric · 13d
Cleared Dec 31, 1990
VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODES
K904560 · Valleylab, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 87d
Cleared Dec 28, 1990
FORCE GSU TM SYSTEM AND FORCE GSU TM HANDSET
K904545 · Valleylab, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 85d
Cleared Dec 24, 1990
AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP
K904588 · United States Surgical, A Division of Tyco Healthc
GAL · Suture, Absorbable, Natural · 89d
Cleared Dec 24, 1990
DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE
K903643 · Deknatel, Inc.
GAW · Suture, Nonabsorbable, Synthetic, Polypropylene · 136d
Cleared Dec 19, 1990
DERMABRADER
K905046 · Aaron Medical Industries
GFE · Brush, Dermabrasion, Powered · 41d
Cleared Dec 19, 1990
HERCULES MODEL 5000 AND 5040 ND:YAG LASER SYSTEMS
K904610 · Heraeus Lasersonics, Inc.
GEX · Powered Laser Surgical Instrument · 69d
Cleared Dec 18, 1990
FLOWERS DORSAL COLUMELLA IMPLANT
K904657 · Implantech Associates, Inc.
FZE · Prosthesis, Nose, Internal · 64d
Cleared Dec 18, 1990
FLOWERS NASAL IMPLANT
K904656 · Implantech Associates, Inc.
FZE · Prosthesis, Nose, Internal · 64d
Cleared Dec 13, 1990
1-CUT ACL GRAFT KNIFE
K905380 · Depuy, Inc.
GDX · Scalpel, One-piece · 13d
Cleared Dec 13, 1990
MODELS 4000,4900,6000,8000,8900, LUXUS 6&100/1700
K904444 · Heraeus Lasersonics, Inc.
GEX · Powered Laser Surgical Instrument · 76d
Cleared Dec 13, 1990
CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM
K904423 · Heraeus Lasersonics, Inc.
GEX · Powered Laser Surgical Instrument · 77d
Cleared Dec 12, 1990
NA NEEDLES
K904667 · Olympus Corp.
GDM · Needle, Aspiration And Injection, Reusable · 58d

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All categories 7715 GEX Powered Laser Surgical Instrument 1150 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