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
7638 General & Plastic Surgery devices
3626–3650 of 7638
Cleared Dec 14, 2012
MEDILAS H LASER FIBERS
K123385 · Dornier Medtech America, Inc.
GEX · Powered Laser Surgical Instrument · 42d
Cleared Dec 11, 2012
PROGRIP LAPAROSCOPIC SELF-FIXATING MESH
K123479 · Sofradim Production
FTL · Mesh, Surgical, Polymeric · 28d
Cleared Dec 03, 2012
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS
K123463 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 24d
Cleared Nov 27, 2012
PICOSURE WORKSTATION
K121346 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 207d
Cleared Nov 21, 2012
HEMASORB APPLY
K121953 · Orthocon, Inc.
MTJ · Wax, Bone · 141d
Cleared Nov 15, 2012
PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR
K113380 · Medtronic, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 365d
Cleared Nov 05, 2012
VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT
K122425 · Depuy Mitek, A Johnson & Johnson Company
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 88d
Cleared Nov 02, 2012
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
K122436 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 84d
Cleared Nov 01, 2012
LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
K122637 · Stryker Spine
FST · Light, Surgical, Fiberoptic · 64d
Cleared Nov 01, 2012
COLLAGEN DENTAL WOUND DRESSINGS
K122115 · Collagen Matrix, Inc.
KGN · Wound Dressing With Animal-derived Material(s) · 107d
Cleared Nov 01, 2012
STRYKER CMF MEDPOR CUSTOMIZED IMPLANT
K121315 · Howmedica Osteonics Corp.
FWP · Prosthesis, Chin, Internal · 183d
Cleared Oct 25, 2012
ENSEAL TRIO TISSUE SEALING DEVICE
K123141 · Ethicon Endo-Surgery, LLC
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 20d
Cleared Oct 25, 2012
INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS
K121921 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 115d
Cleared Oct 23, 2012
ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
K123109 · Covidien
GDW · Staple, Implantable · 19d
Cleared Oct 22, 2012
PHASIX PLUG AND PATCH
K120728 · C.R. Bard, Inc.
OWT · Mesh, Surgical, Absorbable, Abdominal Hernia · 227d
Cleared Oct 18, 2012
SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N
K121861 · Smith & Nephew, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 114d
Cleared Oct 17, 2012
ENDOWRIST STAPLER SYSTEM
K113706 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 306d
Cleared Oct 16, 2012
ACCUMESH DEPLOYMENT SYSTEM
K123066 · Covidien, LLC
ORQ · Mesh, Surgical, Deployer · 15d
Cleared Oct 12, 2012
ME HAIR2GO
K121598 · Syneron Medical, Ltd.
ONF · Powered Light Based Non-laser Surgical Instrument With Thermal Effect · 134d
Cleared Oct 11, 2012
WECK REUSABLE OBTURATOR
K121796 · Teleflexmedical, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 114d
Cleared Oct 05, 2012
REPROCESSED SURGICAL ELECTRIC INSTRUMENT
K120040 · Sterilmed, Inc.
NUJ · Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed · 274d
Cleared Oct 02, 2012
PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING
K122756 · Penumbra, Inc.
JCX · Apparatus, Suction, Ward Use, Portable, Ac-powered · 25d
Cleared Oct 01, 2012
ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH
K122511 · Ethicon Endo-Surgery, LLC
GCJ · Laparoscope, General & Plastic Surgery · 45d
Cleared Sep 25, 2012
ARTHREX SUTURE (UHMWPE)
K122374 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 50d
Cleared Sep 17, 2012
BIOFIBER SYTURE
K122487 · Tornier, Inc.
NWJ · Suture, Recombinant Technology · 33d

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All categories 7638 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1106 GCJ Laparoscope, General & Plastic Surgery 682 FRO Dressing, Wound, Drug 214 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 98 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