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
18256
Total
18211
Cleared
136d
Avg (2y)
1976
Since
7638 General & Plastic Surgery devices
Cleared
Apr 28, 2014
CAIMAN SEAL AND CUT TECHNOLOGY
GEI
Electrosurgical, Cutting & Coagulation & Accessories
26d
Cleared
Apr 28, 2014
EMPRINT ABLATION SYSTEM
NEY
System, Ablation, Microwave And Accessories
133d
Cleared
Apr 22, 2014
ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING
GDW
Staple, Implantable
48d
Cleared
Apr 17, 2014
LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
49d
Cleared
Apr 17, 2014
DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES
NAY
System, Surgical, Computer Controlled Instrument
294d
Cleared
Apr 15, 2014
FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER
GEX
Powered Laser Surgical Instrument
47d
Cleared
Apr 10, 2014
CONTOUR I V3.1 SYSTEM
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
171d
Cleared
Apr 09, 2014
RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS
GDW
Staple, Implantable
30d
Cleared
Mar 28, 2014
DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
NAY
System, Surgical, Computer Controlled Instrument
277d
Cleared
Mar 10, 2014
DERMABOND PRINEO SKIN CLOSURE SYSTEM
OMD
Cutaneous Tissue Adhesive With Mesh
81d
Cleared
Mar 05, 2014
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
134d
Cleared
Feb 28, 2014
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
196d
Cleared
Feb 11, 2014
AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY
MTJ
Wax, Bone
26d
Cleared
Jan 30, 2014
ARTHREX BIOSUTURE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
27d
Cleared
Jan 24, 2014
ATRICURE CRYO MODULE SYSTEM
GEH
Unit, Cryosurgical, Accessories
14d
Cleared
Jan 24, 2014
MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
49d
Cleared
Jan 24, 2014
EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
184d
Cleared
Jan 22, 2014
ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY
GDW
Staple, Implantable
30d
Cleared
Jan 22, 2014
REPROCESSED CLOSURE SYSTEM
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
76d
Cleared
Jan 15, 2014
ILUMINAGE SKIN SMOOTHING LASER
OHS
Light Based Over The Counter Wrinkle Reduction
64d
Cleared
Jan 08, 2014
ENDO GIA(TM) EXTRA LONG ADAPTER
GDW
Staple, Implantable
28d
Cleared
Jan 07, 2014
MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD
GEI
Electrosurgical, Cutting & Coagulation & Accessories
82d
Cleared
Dec 26, 2013
CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS
GEX
Powered Laser Surgical Instrument
62d
Cleared
Dec 19, 2013
VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH
GEX
Powered Laser Surgical Instrument
29d
Cleared
Dec 16, 2013
STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY
GCJ
Laparoscope, General & Plastic Surgery
101d
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