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

18288
Total
18243
Cleared
138d
Avg (2y)
1976
Since
14039 General & Plastic Surgery devices
8526–8550 of 14039
Cleared Aug 10, 1999
FOTONA NOVALIS ER: YAG LASER SYSTEM
K991632 · Fotona D.D.
GEX · Powered Laser Surgical Instrument · 90d
Cleared Aug 10, 1999
FOTONA NOVALIS R RUBY LASER SYSTEM
K991634 · Fotona D.D.
GEX · Powered Laser Surgical Instrument · 90d
Cleared Aug 09, 1999
MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA
K991628 · Esc Medical Systems, Inc.
GEX · Powered Laser Surgical Instrument · 90d
Cleared Aug 06, 1999
VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
K992406 · Mitek Products
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 17d
Cleared Aug 05, 1999
SILGEL STC-S
K984029 · Nagor , Ltd.
MDA · Elastomer, Silicone, For Scar Management · 266d
Cleared Jul 30, 1999
DENTEC LD 15 DIODE LASER
K990680 · Dentek Lasersystems Produktions Ges.M.B.H.
GEX · Powered Laser Surgical Instrument · 150d
Cleared Jul 30, 1999
POLARIS DIODE LASER SYSTEM AND ACCESSORIES
K990914 · Xintec Corporation
GEX · Powered Laser Surgical Instrument · 134d
Cleared Jul 30, 1999
ACIER SUTURES
K991073 · Cardio Thoracic Systems
GAQ · Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile · 121d
Cleared Jul 30, 1999
DERMAPHYLYX FOAM ISLAND DRESSING
K991933 · Dermaphylyx, Inc.
KMF · Bandage, Liquid · 52d
Cleared Jul 30, 1999
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
K991968 · Smith & Nephew, Inc.
MDA · Elastomer, Silicone, For Scar Management · 49d
Cleared Jul 30, 1999
PULSTAR
K992061 · Lasermed, Inc.
GEX · Powered Laser Surgical Instrument · 42d
Cleared Jul 30, 1999
SCARAID SILICONE GEL SHEETING
K992146 · Biodermis Corp.
MDA · Elastomer, Silicone, For Scar Management · 36d
Cleared Jul 30, 1999
QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENT
K992186 · Conmedcorp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 31d
Cleared Jul 30, 1999
DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601
K992218 · Kirwan Surgical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 29d
Cleared Jul 30, 1999
AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE
K992288 · Tyco Intl. (Us), Inc.
GCJ · Laparoscope, General & Plastic Surgery · 23d
Cleared Jul 30, 1999
BLUNT TIP TROCAR PORT
K992353 · Origin Medsystems, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 16d
Cleared Jul 30, 1999
ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBES
K992408 · Oratec Interventions, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 10d
Cleared Jul 29, 1999
UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES
K991659 · Medart Corp.
GEX · Powered Laser Surgical Instrument · 76d
Cleared Jul 29, 1999
GORE-TEX DUALMESH BIOMATERIAL
K992189 · W.L. Gore & Associates, Inc.
FTL · Mesh, Surgical, Polymeric · 30d
Cleared Jul 27, 1999
CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5
K991517 · Galil Medical , Ltd.
GEH · Unit, Cryosurgical, Accessories · 88d
Cleared Jul 20, 1999
CHROMOPHARE D 530 LDR SURGICAL LIGHT
K990656 · Berchtold Holding GmbH
FSY · Light, Surgical, Ceiling Mounted · 141d
Cleared Jul 20, 1999
ENDOSCOPIC CAMERA
K991416 · Genzyme Surgical Product (Genzyme Biosurgery)
GCJ · Laparoscope, General & Plastic Surgery · 88d
Cleared Jul 20, 1999
DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50
K991464 · Fisma, Inc.
GEX · Powered Laser Surgical Instrument · 84d
Cleared Jul 20, 1999
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
K991608 · Dermaphylyx, Inc.
KMF · Bandage, Liquid · 71d
Cleared Jul 20, 1999
DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING
K991609 · Dermaphylyx, Inc.
KMF · Bandage, Liquid · 71d

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 14039 GEX Powered Laser Surgical Instrument 2375 GEI Electrosurgical, Cutting & Coagulation & Accessories 1873 GCJ Laparoscope, General & Plastic Surgery 1114 FRO Dressing, Wound, Drug 574 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 259 GEH Unit, Cryosurgical, Accessories 211 OMP Negative Pressure Wound Therapy Powered Suction Pump 211 KGN Wound Dressing With Animal-derived Material(s) 172 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 161 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 158 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 155