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
13866 General & Plastic Surgery devices
Cleared
May 13, 2008
LITEDUO
GEX
Powered Laser Surgical Instrument
161d
Cleared
May 09, 2008
PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM
MJG
Device, Percutaneous, Biopsy
60d
Cleared
May 09, 2008
OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
105d
Cleared
May 09, 2008
PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS
GEX
Powered Laser Surgical Instrument
150d
Cleared
May 08, 2008
PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY
GCJ
Laparoscope, General & Plastic Surgery
62d
Cleared
May 08, 2008
ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT
OAB
Low Energy Direct Current Thermal Ablation System
101d
Cleared
May 08, 2008
OLYMPUS ESG-100, MODEL WB991046
GEI
Electrosurgical, Cutting & Coagulation & Accessories
177d
Cleared
May 07, 2008
U-CLIP UNI-FIRE, MODEL M65
FZP
Clip, Implantable
21d
Cleared
May 07, 2008
TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
61d
Cleared
May 07, 2008
REVERA WOUND CARE, MODEL MDW0060
FRO
Dressing, Wound, Drug
446d
Cleared
May 06, 2008
HEPATOSTAT SET
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
146d
Cleared
May 05, 2008
SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER
GEX
Powered Laser Surgical Instrument
10d
Cleared
May 05, 2008
ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE
FZP
Clip, Implantable
24d
Cleared
May 05, 2008
AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT
GDW
Staple, Implantable
35d
Cleared
May 02, 2008
MOBLVAC W.C.
BTA
Pump, Portable, Aspiration (manual Or Powered)
7d
Cleared
May 02, 2008
AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING
FRO
Dressing, Wound, Drug
80d
Cleared
May 02, 2008
LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM
FZW
Expander, Surgical, Skin Graft
100d
Cleared
May 02, 2008
ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE
GEX
Powered Laser Surgical Instrument
106d
Cleared
May 01, 2008
SUPRASORB A +AG
FRO
Dressing, Wound, Drug
344d
Cleared
Apr 30, 2008
ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
35d
Cleared
Apr 30, 2008
WG-SURGICAL SUTURES WITH NEEDLE
NEW
Suture, Surgical, Absorbable, Polydioxanone
126d
Cleared
Apr 30, 2008
DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT
GAL
Suture, Absorbable, Natural
197d
Cleared
Apr 29, 2008
TRANSPOSAL ULTRA SYSTEMS
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
15d
Cleared
Apr 25, 2008
IFS LASER SYSTEM
GEX
Powered Laser Surgical Instrument
143d
Cleared
Apr 25, 2008
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
FRO
Dressing, Wound, Drug
324d
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