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
136d
Avg (2y)
1976
Since
7655 General & Plastic Surgery devices
4226–4250 of 7655
Cleared Oct 14, 2004
ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS
K033421 · Erbe USA, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 353d
Cleared Sep 29, 2004
EDWARDS E360 SURGICAL ABLATION DEVICE
K041739 · Edwards Lifesciences, LLC
GEX · Powered Laser Surgical Instrument · 93d
Cleared Sep 28, 2004
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE
K042233 · Depuy Mitek, A Johnson & Johnson Company
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 41d
Cleared Sep 28, 2004
POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE
K042141 · Teleflex Medical
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 50d
Cleared Sep 28, 2004
VALUPEN,PROFILE
K041868 · Conmed Corporation
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 81d
Cleared Sep 24, 2004
MODIFIED SPACEMAKER SYSTEM
K042412 · United States Surgical, A Division of Tyco Healthc
GCJ · Laparoscope, General & Plastic Surgery · 17d
Cleared Sep 14, 2004
MODIFICATION TO OPTICAL SEPARATOR SYSTEM
K041795 · Applied Medical Resources Corp.
GCJ · Laparoscope, General & Plastic Surgery · 74d
Cleared Sep 14, 2004
ATRIUM MEDICAL CORPORATION ICAST COVERED STENT
K041269 · Atrium Medical Corp.
JCT · Prosthesis, Tracheal, Expandable · 125d
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 Sep 09, 2004
VISULAS YAG III
K042139 · Carl Zeiss Meditec, AG
GEX · Powered Laser Surgical Instrument · 31d
Cleared Sep 08, 2004
TRIMEDYNE HOLMIUM LASER SYSTEMS
K041660 · Trimedyne, Inc.
GEX · Powered Laser Surgical Instrument · 82d
Cleared Aug 27, 2004
SYNTHES (USA) TITANIUM WIRE
K041333 · Synthes (Usa)
GAQ · Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile · 100d
Cleared Aug 26, 2004
ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304
K041711 · Applied Medical Resources Corp.
KGW · Ring (wound Protector), Drape Retention, Internal · 64d
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 Aug 03, 2004
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE
K041806 · Depuy Mitek, A Johnson & Johnson Company
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 28d
Cleared Jul 27, 2004
SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTOR
K041328 · Smith & Nephew, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 69d
Cleared Jul 14, 2004
THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
K040756 · Implex Corp.
FTM · Mesh, Surgical · 112d
Cleared Jul 07, 2004
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS
K040237 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 159d
Cleared Jul 01, 2004
ATRICURE DISSECTOR
K041681 · AtriCure, Inc.
FTD · Lamp, Surgical · 10d
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 Jun 04, 2004
LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)
K040699 · Megadyne Medical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 79d
Cleared May 26, 2004
PHOTOSILK PULSED LIGHT SYSTEM
K041095 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 29d

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All categories 7655 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1106 GCJ Laparoscope, General & Plastic Surgery 682 FRO Dressing, Wound, Drug 216 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 101 FZP Clip, Implantable 100 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