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
14018 General & Plastic Surgery devices
8151–8175 of 14018
Cleared Jun 18, 2001
LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD113
K010870 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 87d
Cleared Jun 14, 2001
SLT LASERPRO CTH HOLMIUM LASER SYSTEM
K011409 · Surgical Laser Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 37d
Cleared May 31, 2001
LAPAROSCOPIC HAND PORT
K003871 · Applied Medical Resources Corp.
GCJ · Laparoscope, General & Plastic Surgery · 167d
Cleared May 31, 2001
ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145
K010898 · Ethicon Endo-Surgery, Inc.
LFL · Instrument, Ultrasonic Surgical · 66d
Cleared May 30, 2001
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000
K011002 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 57d
Cleared May 25, 2001
AMBU GEL, HYDROGEL BURN DRESSING
K010583 · Ambu, Inc.
MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 87d
Cleared May 22, 2001
PALOMAR SLP 1000
K010580 · Palomar Medical Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 84d
Cleared May 21, 2001
LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
K010834 · Laserscope
GEX · Powered Laser Surgical Instrument · 62d
Cleared May 21, 2001
MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K010936 · W.L. Gore & Associates, Inc.
OXD · Mesh, Surgical, Non-absorbable, Staple Line Reinforcement · 54d
Cleared May 18, 2001
MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM
K010689 · Biolitec, Inc.
GEX · Powered Laser Surgical Instrument · 71d
Cleared May 14, 2001
DENSTAT
K010465 · Elmed, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 87d
Cleared May 14, 2001
ARTHREX FIBERWIRE, MODEL SPU-02NB-3800
K010673 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 69d
Cleared May 14, 2001
MODIFICATION TO IMPLANTABLE CLIP
K011236 · Applied Medical Resources Corp.
FZP · Clip, Implantable · 21d
Cleared May 11, 2001
BIOKNOTLESS ANCHOR
K002639 · Mitek Products
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 260d
Cleared May 07, 2001
XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE
K010666 · Medtronic Xomed, Inc.
QPB · System, Suction, Lipoplasty For Removal · 62d
Cleared May 03, 2001
TANTALUM BEADS - RADIOGRAPHIC MARKER
K010348 · Biomet, Inc.
NEU · Marker, Radiographic, Implantable · 87d
Cleared May 03, 2001
SEEDNET, MODELS FP6T5, FP5T5, FP5T3
K010991 · Galil Medical , Ltd.
GEH · Unit, Cryosurgical, Accessories · 30d
Cleared May 02, 2001
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
K010346 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 86d
Cleared May 01, 2001
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
K010284 · Laserscope
GEX · Powered Laser Surgical Instrument · 90d
Cleared Apr 27, 2001
PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
K010722 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 46d
Cleared Apr 27, 2001
CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1
K010789 · A & A Medical, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 43d
Cleared Apr 23, 2001
MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
K010709 · Mentor Corp.
MRD · Mammary Sizer · 45d
Cleared Apr 20, 2001
SONOTOME ULTRASONIC ASPIRATOR TIPS
K010637 · Synergetics, Inc.
LFL · Instrument, Ultrasonic Surgical · 46d
Cleared Apr 13, 2001
COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X
K010956 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 14d
Cleared Apr 11, 2001
CANDELA LONG PULSE ND:YAG
K010104 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 89d

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All categories 14018 GEX Powered Laser Surgical Instrument 2373 GEI Electrosurgical, Cutting & Coagulation & Accessories 1872 GCJ Laparoscope, General & Plastic Surgery 1113 FRO Dressing, Wound, Drug 574 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 257 OMP Negative Pressure Wound Therapy Powered Suction Pump 211 GEH Unit, Cryosurgical, Accessories 211 KGN Wound Dressing With Animal-derived Material(s) 171 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 159 EFQ Gauze/sponge, Internal 157 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 157 KMF Bandage, Liquid 155