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

18201
Total
18157
Cleared
138d
Avg (2y)
1976
Since
4109 General & Plastic Surgery devices
3426–3450 of 4109
Cleared Sep 02, 2005
ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
K050411 · Zimmer, Inc.
KCY · Tourniquet, Pneumatic · 197d
Cleared Aug 11, 2005
SCB/STERIS OR-LIGHT INTERFACE BOX
K051505 · KARL STORZ Endoscopy-America, Inc.
FTA · Light, Surgical, Accessories · 65d
Cleared Aug 09, 2005
ENDOSCOPIC APPLICATOR
K051732 · Ethicon, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 42d
Cleared Jun 29, 2005
MONOCRYL PLUS ANTIBACTERIAL SUTURE
K050845 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 86d
Cleared Jun 09, 2005
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
K042164 · Medline Industries, Inc.
FRO · Dressing, Wound, Drug · 302d
Cleared Jun 08, 2005
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
K051125 · Abbott Laboratories
FZP · Clip, Implantable · 36d
Cleared Jun 01, 2005
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
K050947 · United States Surgical, A Division of Tyco Healthc
GAW · Suture, Nonabsorbable, Synthetic, Polypropylene · 47d
Cleared May 27, 2005
MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE
K042606 · Synthes (Usa)
GAQ · Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile · 245d
Cleared May 25, 2005
SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX
K050898 · Smith & Nephew, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 44d
Cleared Apr 21, 2005
ACTICOAT MOISTURE CONTROL DRESSING
K050030 · Smith & Nephew, Inc.
FRO · Dressing, Wound, Drug · 104d
Cleared Mar 14, 2005
MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE
K050361 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 28d
Cleared Dec 21, 2004
CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884
K043291 · Medtronic Vascular
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 22d
Cleared Dec 10, 2004
ARTHREX SUTURE GRAFTING KIT
K041553 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 184d
Cleared Nov 02, 2004
3M TEGADERM SILVER
K040890 · 3M Company
FRO · Dressing, Wound, Drug · 223d
Cleared Sep 24, 2004
MODIFIED SPACEMAKER SYSTEM
K042412 · United States Surgical, A Division of Tyco Healthc
GCJ · Laparoscope, General & Plastic Surgery · 17d
Cleared Sep 10, 2004
BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004
K042026 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 44d
Cleared Aug 27, 2004
SYNTHES (USA) TITANIUM WIRE
K041333 · Synthes (Usa)
GAQ · Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile · 100d
Cleared Aug 06, 2004
DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682
K041827 · Boston Scientific Corp
GCJ · Laparoscope, General & Plastic Surgery · 30d
Cleared Aug 05, 2004
ARTHREX FIBERWIRE WITH SILK
K041589 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 55d
Cleared Jul 27, 2004
SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTOR
K041328 · Smith & Nephew, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 69d
Cleared Jul 01, 2004
DAVOL DELIVERY SYSTEM
K041641 · C.R. Bard, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 14d
Cleared Jun 07, 2004
SMITH & NEPHEW ULTRABRAID SUTURE
K041216 · Smith & Nephew, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 28d
Cleared Jun 04, 2004
DURABRAID SUTURE
K040789 · Smith & Nephew, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 67d
Cleared Apr 28, 2004
CONCERTO BIPOLAR NEEDLE ELECTRODE
K040785 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 30d
Cleared Apr 22, 2004
RESOLUTION HEMOSTASIS CLIPPING DEVICE
K040148 · Boston Scientific Corp
MCH · Clip, Hemostatic · 90d

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All categories 4109 GEI Electrosurgical, Cutting & Coagulation & Accessories 539 GEX Powered Laser Surgical Instrument 498 GCJ Laparoscope, General & Plastic Surgery 334 FRO Dressing, Wound, Drug 163 OHT Light Based Over-the-counter Hair Removal 142 OHS Light Based Over The Counter Wrinkle Reduction 118 GDW Staple, Implantable 107 NAY System, Surgical, Computer Controlled Instrument 99 FTL Mesh, Surgical, Polymeric 95 OMP Negative Pressure Wound Therapy Powered Suction Pump 93 KGN Wound Dressing With Animal-derived Material(s) 74 OAP Laser, Comb, Hair 72 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 71 GAM Suture, Absorbable, Synthetic, Polyglycolic Acid 62 GEH Unit, Cryosurgical, Accessories 62