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
13992 General & Plastic Surgery devices
Cleared
Dec 18, 2003
AMI REPROCESSED MULTIPLE CLIP APPLIERS
FZP
Clip, Implantable
85d
Cleared
Dec 18, 2003
COAPT ENDOTINE CHIN 3.5 DEVICE
HWC
Screw, Fixation, Bone
41d
Cleared
Dec 18, 2003
VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE
QSX
Hemostatic Wound Dressing With Thrombin Or Other Biologics
22d
Cleared
Dec 18, 2003
MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
17d
Cleared
Dec 15, 2003
TRIDENT RESECTION ABLATOR
GEI
Electrosurgical, Cutting & Coagulation & Accessories
14d
Cleared
Dec 10, 2003
ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
OCW
Endoscopic Tissue Approximation Device
62d
Cleared
Dec 10, 2003
MODIFICATION TO AURORA DS
GEX
Powered Laser Surgical Instrument
27d
Cleared
Dec 09, 2003
MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM
LFL
Instrument, Ultrasonic Surgical
98d
Cleared
Dec 03, 2003
CANDELA SMOOTHBEAM LASER SYSTEM
GEX
Powered Laser Surgical Instrument
261d
Cleared
Dec 02, 2003
STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
76d
Cleared
Dec 01, 2003
POLARIS WR
GEX
Powered Laser Surgical Instrument
186d
Cleared
Dec 01, 2003
AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT
GDW
Staple, Implantable
90d
Cleared
Nov 28, 2003
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
FTL
Mesh, Surgical, Polymeric
77d
Cleared
Nov 28, 2003
MALIS IRRIGATION MODULE 1000
GEI
Electrosurgical, Cutting & Coagulation & Accessories
23d
Cleared
Nov 28, 2003
ARTHROCARE ARTHROWANDS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
15d
Cleared
Nov 26, 2003
OPTIMESH
EZX
Mesh, Surgical, Metal
705d
Cleared
Nov 20, 2003
ARAMIS II DERMATOLOGICAL LASER
GEX
Powered Laser Surgical Instrument
121d
Cleared
Nov 20, 2003
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE
GEX
Powered Laser Surgical Instrument
45d
Cleared
Nov 17, 2003
AURA ISURGICAL LASER SYSTEM & ACCESSORIES
GEX
Powered Laser Surgical Instrument
332d
Cleared
Nov 17, 2003
CYNOSURE PHOTOGENICA SV LASER
GEX
Powered Laser Surgical Instrument
91d
Cleared
Nov 17, 2003
CAPROSYN ABSORBABLE SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
87d
Cleared
Nov 17, 2003
ORTHODEK
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
48d
Cleared
Nov 13, 2003
PROFILE BBL SYSTEM
GEX
Powered Laser Surgical Instrument
94d
Cleared
Nov 10, 2003
RELIANT LASER SYSTEM
GEX
Powered Laser Surgical Instrument
153d
Cleared
Oct 30, 2003
ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR
GCJ
Laparoscope, General & Plastic Surgery
62d
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