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
14161 General & Plastic Surgery devices
10526–10550 of 14161
Cleared Oct 17, 1994
AMSCO SQ240 SURGICAL LIGHT
K943288 · American Sterilizer Co.
FSY · Light, Surgical, Ceiling Mounted · 101d
Cleared Oct 07, 1994
KARL STORZ INSULATED SCISSORS AND RECTAL SNARES
K944530 · KARL STORZ Endoscopy-America, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 23d
Cleared Oct 03, 1994
CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING
K940249 · Certified Safety Mfg., Inc.
LRR · First Aid Kit With Drug · 257d
Cleared Oct 03, 1994
CUSH ISLAND DRESSING
K943424 · Cush Medical Products
MGP · Dressing, Wound And Burn, Occlusive · 80d
Cleared Oct 03, 1994
CURADERM ALGINATE HYDROCOLLOID
K943636 · Kendall Healthcare Products Co. Div.Of Tyco Health
KMF · Bandage, Liquid · 68d
Cleared Oct 03, 1994
AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTS
K944467 · Aesculap, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 24d
Cleared Sep 30, 1994
CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASER
K944090 · Candela Laser Corp.
GEX · Powered Laser Surgical Instrument · 39d
Cleared Sep 29, 1994
GORE-TEX SOFT TISSUE PATCH PLUS
K922452 · W.L. Gore & Associates, Inc.
FTL · Mesh, Surgical, Polymeric · 856d
Cleared Sep 28, 1994
GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER
K942574 · Acufex Microsurgical, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 120d
Cleared Sep 27, 1994
CONBIO CUB-D10 COOPER LASER SYSTEM
K942934 · Continuum Biomedical, Inc.
GEX · Powered Laser Surgical Instrument · 97d
Cleared Sep 27, 1994
IRRIGATION/BIPOLAR SET
K942944 · Surgin Surgical Instrumentation, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 97d
Cleared Sep 23, 1994
IRRIGATION/ASPIRATION INSTRUMENT
K942306 · Megadyne Medical Products, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 133d
Cleared Sep 23, 1994
FORCE GSU-SLPM SYSTEM
K943865 · Valleylab, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 46d
Cleared Sep 23, 1994
ORIGIN BALLOON ANCHOR
K944304 · Origin Medsystems, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 21d
Cleared Sep 21, 1994
FORCE GSU SYSTEM MODEL NO. GSU-20 AND GSU-22
K942579 · Valleylab, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 113d
Cleared Sep 20, 1994
CROSSFIRE(TM) (705-10650)
K943171 · Cardiogenes
GEX · Powered Laser Surgical Instrument · 96d
Cleared Sep 20, 1994
KARL STORZ FLUID LIGHT CABLES
K944224 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 21d
Cleared Sep 16, 1994
CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS.
K931902 · Valleylab, Inc.
LFL · Instrument, Ultrasonic Surgical · 515d
Cleared Sep 16, 1994
KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH
K935277 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 317d
Cleared Sep 16, 1994
KARL STORZ LASER ACCESSORIES
K942786 · KARL STORZ Endoscopy-America, Inc.
GEX · Powered Laser Surgical Instrument · 94d
Cleared Sep 16, 1994
END-O-FOG ENDOSCOPIC FOG ELIMINATION SYSTEM
K943927 · American Hydro-Surgical Instruments, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 35d
Cleared Sep 12, 1994
KARL STORZ HOPKINS I RIGID AUTOCLAVABLE TELESCOPE, KARL STORZ HOPKINS II RIGID AUTOCLAVABLE TELESCOPE
K935279 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 313d
Cleared Sep 07, 1994
KARL STORZ THORACIC SURGERY INSTRUMENTS
K940427 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 219d
Cleared Sep 06, 1994
AUTO SUTURE DISPOSABLE ENDOSCOPE SHEATH
K934704 · United States Surgical, A Division of Tyco Healthc
GCJ · Laparoscope, General & Plastic Surgery · 341d
Cleared Sep 06, 1994
DISPOSABLE LAPAROSCOPIC SWAB WITH REUSABLE HANDLE
K943970 · Cook Ob/Gyn
GCJ · Laparoscope, General & Plastic Surgery · 22d

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All categories 14161 GEX Powered Laser Surgical Instrument 2394 GEI Electrosurgical, Cutting & Coagulation & Accessories 1900 GCJ Laparoscope, General & Plastic Surgery 1122 FRO Dressing, Wound, Drug 584 FTL Mesh, Surgical, Polymeric 317 GDW Staple, Implantable 262 GEH Unit, Cryosurgical, Accessories 214 OMP Negative Pressure Wound Therapy Powered Suction Pump 213 KGN Wound Dressing With Animal-derived Material(s) 174 OHT Light Based Over-the-counter Hair Removal 163 NAY System, Surgical, Computer Controlled Instrument 163 OHS Light Based Over The Counter Wrinkle Reduction 161 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 160 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 155