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
13747 General & Plastic Surgery devices
Cleared
Dec 20, 2013
SUNETICS CLINICAL BIO-STIMULATION LASER
OAP
Laser, Comb, Hair
116d
Cleared
Dec 20, 2013
NIVATOPIC PLUS
FRO
Dressing, Wound, Drug
147d
Cleared
Dec 20, 2013
BARLE TISSUE ADHESIVE 2
MPN
Tissue Adhesive For The Topical Approximation Of Skin
155d
Cleared
Dec 19, 2013
VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH
GEX
Powered Laser Surgical Instrument
29d
Cleared
Dec 19, 2013
LINA POWERBLADE PLUS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
100d
Cleared
Dec 19, 2013
YOUNG AGAIN
OHS
Light Based Over The Counter Wrinkle Reduction
353d
Cleared
Dec 18, 2013
SURGEN U
GEI
Electrosurgical, Cutting & Coagulation & Accessories
184d
Cleared
Dec 16, 2013
STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY
GCJ
Laparoscope, General & Plastic Surgery
101d
Cleared
Dec 16, 2013
HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE
LFL
Instrument, Ultrasonic Surgical
126d
Cleared
Dec 16, 2013
HYALMIX CREAM
FRO
Dressing, Wound, Drug
381d
Cleared
Dec 13, 2013
BARD VENTRALEX HERNIA PATCH
FTL
Mesh, Surgical, Polymeric
129d
Cleared
Dec 13, 2013
ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS
GDW
Staple, Implantable
270d
Cleared
Dec 12, 2013
NEOGEN PSR SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
100d
Cleared
Dec 11, 2013
ERBE ESU MODEL VIO DV WITH ACCESSORIES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
55d
Cleared
Dec 11, 2013
ULTHERA SYSTEM
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
163d
Cleared
Dec 11, 2013
ME
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
189d
Cleared
Dec 11, 2013
WOUND MEASURING & MONITORING DEVICE
FXN
Tape, Camera, Surgical
191d
Cleared
Dec 11, 2013
RETRIEVAL BAG
GCJ
Laparoscope, General & Plastic Surgery
372d
Cleared
Dec 06, 2013
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
36d
Cleared
Dec 06, 2013
FAMILY OF COOLGLIDE AESTHETIC LASERS
GEX
Powered Laser Surgical Instrument
144d
Cleared
Dec 06, 2013
SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
269d
Cleared
Dec 05, 2013
SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
FTD
Lamp, Surgical
27d
Cleared
Dec 05, 2013
TFCC FAST-FIX KIT
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
153d
Cleared
Dec 05, 2013
DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS
GEX
Powered Laser Surgical Instrument
231d
Cleared
Dec 03, 2013
HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY
LFL
Instrument, Ultrasonic Surgical
36d
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