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
14186 General & Plastic Surgery devices
10926–10950 of 14186
Cleared Dec 17, 1993
SUTURES
K930360 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 325d
Cleared Dec 17, 1993
NON-ABSORBABLE SURGICAL SUTURES
K930517 · Alcon Laboratories
GAR · Suture, Nonabsorbable, Synthetic, Polyamide · 319d
Cleared Dec 17, 1993
DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT
K930586 · Davis & Geck, Inc.
GAR · Suture, Nonabsorbable, Synthetic, Polyamide · 316d
Cleared Dec 17, 1993
SURGILENE POLYPROPYLENE SUTURE
K930587 · Davis & Geck, Inc.
GAW · Suture, Nonabsorbable, Synthetic, Polypropylene · 316d
Cleared Dec 17, 1993
PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTUR
K930589 · Davis & Geck, Inc.
GAL · Suture, Absorbable, Natural · 316d
Cleared Dec 17, 1993
SILK SUTURES
K930590 · Davis & Geck, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 316d
Cleared Dec 17, 1993
TI-CRON AND DACRON SUTURES
K930591 · Davis & Geck, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 316d
Cleared Dec 17, 1993
NYLAMID SUTURE
K931612 · S. Jackson, Inc.
GAR · Suture, Nonabsorbable, Synthetic, Polyamide · 260d
Cleared Dec 17, 1993
SUPRAMID SUTURE
K931613 · S. Jackson, Inc.
GAR · Suture, Nonabsorbable, Synthetic, Polyamide · 260d
Cleared Dec 17, 1993
MOPYLEN SUTURE
K931614 · S. Jackson, Inc.
GAW · Suture, Nonabsorbable, Synthetic, Polypropylene · 260d
Cleared Dec 17, 1993
PHX TECHNOLOGIES CORP., BOWEL GRASPER DEVICE
K934021 · Phx Technologies Corp.
GCJ · Laparoscope, General & Plastic Surgery · 122d
Cleared Dec 17, 1993
PHX TECH SINGLE ACTION HEAVY-TOOTH JAW CLAW GRASPER
K934022 · Phx Technologies Corp.
GCJ · Laparoscope, General & Plastic Surgery · 122d
Cleared Dec 17, 1993
PHX TECHNOLOGIES CORP., ALTRAUMATIC GRASPER DEVICE
K934023 · Phx Technologies Corp.
GCJ · Laparoscope, General & Plastic Surgery · 122d
Cleared Dec 17, 1993
PHX TECHNOLOGIES CORP., SUTURE GRASPER DEVICE
K934024 · Phx Technologies Corp.
GCJ · Laparoscope, General & Plastic Surgery · 122d
Cleared Dec 17, 1993
PHX TECHNOLOGIES CORP, SPONGE GRASPER DEVICE
K934025 · Phx Technologies Corp.
GCJ · Laparoscope, General & Plastic Surgery · 122d
Cleared Dec 17, 1993
PHX TECHNOLOGIES CORP. BOWEL GRASPER DEVICE
K934026 · Phx Technologies Corp.
GCJ · Laparoscope, General & Plastic Surgery · 122d
Cleared Dec 17, 1993
PHX TECHNOLOGIES CORP., ALLIGATOR GRASPER DEVICE
K934027 · Phx Technologies Corp.
GCJ · Laparoscope, General & Plastic Surgery · 122d
Cleared Dec 17, 1993
PHX TECHNOLOGIES CORP.,10MM STERILE, DISPOSABLE POOL TIP SUCTION CANNULA
K934078 · Phx Technologies Corp.
GCJ · Laparoscope, General & Plastic Surgery · 119d
Cleared Dec 16, 1993
ATRIUM POLYPROPYLENE MESH
K930669 · Atrium Medical Corp.
FTL · Mesh, Surgical, Polymeric · 308d
Cleared Dec 16, 1993
STERILE, DISPOSABLE ENDOSCOPIC TRUMPET VALVE
K934098 · Phx Technologies Corp.
GCJ · Laparoscope, General & Plastic Surgery · 115d
Cleared Dec 16, 1993
TROCAR REDUCER WITH GAS CLHECK VALVE
K934185 · Phx Technologies Corp.
GCJ · Laparoscope, General & Plastic Surgery · 112d
Cleared Dec 16, 1993
UVISOL AND UVISOL II
K934808 · National Biological Corp.
FTC · Light, Ultraviolet, Dermatological · 70d
Cleared Dec 14, 1993
ZEISS OPMILAS 144 SURGICAL LASERS
K932376 · Carl Zeiss, Inc.
GEX · Powered Laser Surgical Instrument · 211d
Cleared Dec 13, 1993
MEDSURG MARSHMALLOW TRAY
K920421 · Medsurg Industries, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 682d
Cleared Dec 13, 1993
MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSING
K933689 · Kendall Healthcare Products Co. Div.Of Tyco Health
KMF · Bandage, Liquid · 137d

Looking for a specific general & plastic surgery device? Search by device name, K-number or manufacturer.

Search all General & Plastic Surgery 510(k) devices

Filter by Product Code

All categories 14186 GEX Powered Laser Surgical Instrument 2400 GEI Electrosurgical, Cutting & Coagulation & Accessories 1906 GCJ Laparoscope, General & Plastic Surgery 1123 FRO Dressing, Wound, Drug 586 FTL Mesh, Surgical, Polymeric 317 GDW Staple, Implantable 263 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