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
13853 General & Plastic Surgery devices
Cleared
May 23, 2008
ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM
GEX
Powered Laser Surgical Instrument
255d
Cleared
May 22, 2008
MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS
GCJ
Laparoscope, General & Plastic Surgery
112d
Cleared
May 21, 2008
ECHELON GRAY CARTRIDGE, MODEL ERC45M
GDW
Staple, Implantable
57d
Cleared
May 21, 2008
SONOCA 180/195 WOUND CARE SYSTEM
LFL
Instrument, Ultrasonic Surgical
223d
Cleared
May 20, 2008
NEUTROPHASE
KMF
Bandage, Liquid
42d
Cleared
May 19, 2008
MODIFICATION TO 3M TEGADERM CHG DRESSING
FRO
Dressing, Wound, Drug
76d
Cleared
May 15, 2008
HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
52d
Cleared
May 15, 2008
COLLAGEN TENDON WRAP
FTM
Mesh, Surgical
86d
Cleared
May 15, 2008
BIOSYAG MEDICAL SYSTEM
GEX
Powered Laser Surgical Instrument
93d
Cleared
May 14, 2008
STYLA MICROLASER AND STYLAORTHO
GEX
Powered Laser Surgical Instrument
14d
Cleared
May 14, 2008
3 CCD ENDOCAM 5550
GCJ
Laparoscope, General & Plastic Surgery
37d
Cleared
May 14, 2008
SIALO BALLOON DILATATION CATHETER
GCJ
Laparoscope, General & Plastic Surgery
230d
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
Looking for a specific general & plastic surgery device? Search by device name, K-number or manufacturer.
Search all General & Plastic Surgery 510(k) devices