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
14034 General & Plastic Surgery devices
Cleared
Nov 22, 1999
SUTURE CLINCH
GCJ
Laparoscope, General & Plastic Surgery
90d
Cleared
Nov 18, 1999
STAR TEMPORARY WOUND COVER
FTL
Mesh, Surgical, Polymeric
398d
Cleared
Nov 18, 1999
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
JCT
Prosthesis, Tracheal, Expandable
114d
Cleared
Nov 18, 1999
OPTILITE IX LASER SURGERY ACCESSORIES
GEX
Powered Laser Surgical Instrument
85d
Cleared
Nov 18, 1999
AURORA SL
GEX
Powered Laser Surgical Instrument
49d
Cleared
Nov 17, 1999
PHACOLASE ER: YAG LASER
GEX
Powered Laser Surgical Instrument
156d
Cleared
Nov 17, 1999
LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPHTHALMIC LASER, MODEL
GEX
Powered Laser Surgical Instrument
86d
Cleared
Nov 17, 1999
NON-STICK BIPOLAR FORCEPS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
78d
Cleared
Nov 16, 1999
UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F
GEI
Electrosurgical, Cutting & Coagulation & Accessories
18d
Cleared
Nov 08, 1999
DORNIER SCANNER HANDPIECE
GEX
Powered Laser Surgical Instrument
49d
Cleared
Nov 08, 1999
CASTLE SURGICAL LIGHT, MODEL 3000
FSY
Light, Surgical, Ceiling Mounted
42d
Cleared
Nov 05, 1999
ANTIBACTERIAL ADHESIVE BANDAGE
FRO
Dressing, Wound, Drug
77d
Cleared
Nov 03, 1999
NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)
HAM
Apparatus, Electrosurgical
30d
Cleared
Oct 29, 1999
OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A
GEX
Powered Laser Surgical Instrument
88d
Cleared
Oct 27, 1999
TUBULAR ELECTRODE DEVICE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
89d
Cleared
Oct 27, 1999
BARIATRIC LAPAROSCOPE, MODEL 367
GCJ
Laparoscope, General & Plastic Surgery
47d
Cleared
Oct 26, 1999
SPECTRUM DESIGNS SPECTRAGEL
MDA
Elastomer, Silicone, For Scar Management
90d
Cleared
Oct 25, 1999
ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
203d
Cleared
Oct 25, 1999
MICROWAVE DELIVERY SYSTEM, MODEL MMC-300
MWY
System, Microwave, Hair Removal
182d
Cleared
Oct 25, 1999
SCAREASE SHEETS & SCAREASE GEL
MDA
Elastomer, Silicone, For Scar Management
136d
Cleared
Oct 25, 1999
SELECT-SUTTER MICRO BIPOLAR FORCEPS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
69d
Cleared
Oct 22, 1999
SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600
GEI
Electrosurgical, Cutting & Coagulation & Accessories
23d
Cleared
Oct 19, 1999
MCL 29 DERMABLATE ER:YAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
69d
Cleared
Oct 14, 1999
SIMPLICARE TRANSPARENT WOUND DRESSING
MGP
Dressing, Wound And Burn, Occlusive
188d
Cleared
Oct 14, 1999
SURGITRON RADIOLASE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
90d
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