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
7643 General & Plastic Surgery devices
3826–3850 of 7643
Cleared Sep 28, 2009
SPINEWAND SURGICAL DEVICE
K091228 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 154d
Cleared Sep 15, 2009
ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75)
K092577 · Ethicon Endo-Surgery, LLC
GDW · Staple, Implantable · 25d
Cleared Sep 11, 2009
D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505
K092612 · Vascular Solutions, Inc.
QSX · Hemostatic Wound Dressing With Thrombin Or Other Biologics · 16d
Cleared Sep 03, 2009
CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH
K091537 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 100d
Cleared Aug 26, 2009
ERBE HYBRID KNIFE
K083608 · Erbe USA, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 264d
Cleared Aug 13, 2009
G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE
K080844 · Gyrus Acmi, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 505d
Cleared Aug 03, 2009
BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
K091659 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 55d
Cleared Jul 30, 2009
ATLAS WOUND MATRIX
K090954 · Wrightmedicaltechnologyinc
KGN · Wound Dressing With Animal-derived Material(s) · 115d
Cleared Jul 22, 2009
ACTICOAT FLEX 7 DRESSING
K083113 · Smith & Nephew, Inc.
FRO · Dressing, Wound, Drug · 274d
Cleared Jul 09, 2009
LITHO LASER SYSTEM
K091909 · Quanta System Spa
GEX · Powered Laser Surgical Instrument · 14d
Cleared Jul 09, 2009
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059
K091470 · Smith & Nephew, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 52d
Cleared Jun 23, 2009
ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144
K090393 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 126d
Cleared Jun 23, 2009
CODMAN ISOCOOL BIPOLAR FORCEPS
K083895 · Codman & Shurtleff, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 176d
Cleared Jun 19, 2009
VARI-LASE PLATINUM BRIGHT TIP LASER FIBER
K091551 · Vascular Solutions, Inc.
GEX · Powered Laser Surgical Instrument · 23d
Cleared Jun 19, 2009
CYBER SURGICAL LASER FAMILY INCLUDING: CYBER TM, CYBER GREEN, CYBER GREEN TM
K090962 · Quanta System Spa
GEX · Powered Laser Surgical Instrument · 74d
Cleared Jun 04, 2009
C-QUR V -PATCH MESH
K090909 · Atrium Medical Corp.
FTL · Mesh, Surgical, Polymeric · 64d
Cleared Jun 02, 2009
PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
K090934 · American Medical Systems, Inc.
FTL · Mesh, Surgical, Polymeric · 61d
Cleared Jun 02, 2009
MEGAPULSE LASER SYSTEM AND FIBERS
K090776 · Richard Wolf Medical Instruments Corp.
GEX · Powered Laser Surgical Instrument · 71d
Cleared Jun 02, 2009
NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
K090630 · Nobel Biocare AB
FZE · Prosthesis, Nose, Internal · 85d
Cleared Jun 01, 2009
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G
K091322 · Ethicon Endo-Surgery, Inc.
GDW · Staple, Implantable · 27d
Cleared May 14, 2009
AUTOSUTURE PROTACK
K090470 · Covidien
OCW · Endoscopic Tissue Approximation Device · 80d
Cleared May 13, 2009
ELITE MPX LASER SYSTEM WITH CRYO C
K091169 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 21d
Cleared May 07, 2009
INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT
K082497 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 251d
Cleared May 06, 2009
PARIETEX MONOFILAMENT POLYESTER MESH
K090858 · Sofradim Production
FTL · Mesh, Surgical, Polymeric · 37d
Cleared Apr 28, 2009
ORTHOSTAT
K091121 · Orthocon, Inc.
MTJ · Wax, Bone · 11d

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All categories 7643 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1106 GCJ Laparoscope, General & Plastic Surgery 682 FRO Dressing, Wound, Drug 215 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