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
13797 General & Plastic Surgery devices
Cleared
May 03, 2012
HALO90 ULTRA ABLATION CATHETER
GEI
Electrosurgical, Cutting & Coagulation & Accessories
80d
Cleared
May 02, 2012
ACCUMESH DEPLOYMENT SYSTEM
ORQ
Mesh, Surgical, Deployer
16d
Cleared
May 02, 2012
ZELTIQ COOLSCULPTING
OOK
Dermal Cooling Pack/vacuum/massager
120d
Cleared
Apr 30, 2012
SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE
NAY
System, Surgical, Computer Controlled Instrument
97d
Not Cleared
Apr 30, 2012
PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS
OXT
Percutaneous Surgical Set With Attachments
222d
Cleared
Apr 27, 2012
EPIFLO(R)
KPJ
Chamber, Oxygen, Topical, Extremity
45d
Cleared
Apr 27, 2012
ECHOTIP(R) ULTRA FIDUCIAL NEEDLE
NEU
Marker, Radiographic, Implantable
297d
Cleared
Apr 26, 2012
C-QUR RPM MESH
FTL
Mesh, Surgical, Polymeric
17d
Cleared
Apr 26, 2012
TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM
GEX
Powered Laser Surgical Instrument
73d
Cleared
Apr 24, 2012
EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)
GEX
Powered Laser Surgical Instrument
90d
Cleared
Apr 20, 2012
CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES
OWN
Confocal Optical Imaging
87d
Cleared
Apr 20, 2012
SALINE WOUND WASH
FRO
Dressing, Wound, Drug
220d
Cleared
Apr 19, 2012
NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
146d
Cleared
Apr 18, 2012
ON CALL CHOSEN LANCING DEVICE
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
156d
Cleared
Apr 16, 2012
SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER
GCJ
Laparoscope, General & Plastic Surgery
67d
Cleared
Apr 13, 2012
SMARTEPIL,DEPILASE YAG LASE PLUS
GEX
Powered Laser Surgical Instrument
262d
Cleared
Apr 12, 2012
CURAD ANTIBACTERIAL BANDAGE
FRO
Dressing, Wound, Drug
129d
Cleared
Apr 12, 2012
HEMCON HEMOSTATIC GEL
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
254d
Cleared
Apr 12, 2012
NATURALASE CO2 LASER SYSTEM
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
434d
Cleared
Apr 09, 2012
PIXEL APP
LWH
Counter, Sponge, Surgical
53d
Cleared
Apr 06, 2012
SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND
GEI
Electrosurgical, Cutting & Coagulation & Accessories
85d
Cleared
Apr 06, 2012
ARTHREX BIO-SUTURE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
186d
Cleared
Apr 06, 2012
ETHEREA
GEX
Powered Laser Surgical Instrument
220d
Cleared
Apr 05, 2012
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES
FRO
Dressing, Wound, Drug
17d
Cleared
Apr 05, 2012
ADVANTAGE LASER SYSTEM
GEX
Powered Laser Surgical Instrument
132d
Looking for a specific general & plastic surgery device? Search by device name, K-number or manufacturer.
Search all General & Plastic Surgery 510(k) devices