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
13808 General & Plastic Surgery devices
Cleared
Oct 17, 2011
EZ VEIN INFLATABLE TOURNIQUET
KCY
Tourniquet, Pneumatic
17d
Cleared
Oct 17, 2011
UNIMAX TROCAR SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
62d
Cleared
Oct 14, 2011
PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX
FTM
Mesh, Surgical
143d
Cleared
Oct 07, 2011
MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY
NAY
System, Surgical, Computer Controlled Instrument
60d
Cleared
Oct 07, 2011
ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK
GEH
Unit, Cryosurgical, Accessories
99d
Cleared
Oct 07, 2011
VENUS SWAN SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
108d
Cleared
Oct 07, 2011
RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
KAM
Cannula, Sinus
210d
Cleared
Oct 05, 2011
CANDELA GENTLEMAX FAMILY OF LASERS
GEX
Powered Laser Surgical Instrument
16d
Cleared
Oct 04, 2011
ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
GCJ
Laparoscope, General & Plastic Surgery
40d
Cleared
Oct 03, 2011
ETWO SKIN TREATMENT SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
208d
Cleared
Oct 03, 2011
EXCELLAGEN
KGN
Wound Dressing With Animal-derived Material(s)
243d
Cleared
Sep 30, 2011
RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
GEX
Powered Laser Surgical Instrument
37d
Cleared
Sep 30, 2011
SURGISTEER SCISSORS, SURGISTEER DISSECTOR / GRASPER, SURGISTEER HOOK
GEI
Electrosurgical, Cutting & Coagulation & Accessories
133d
Cleared
Sep 29, 2011
5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT
NAY
System, Surgical, Computer Controlled Instrument
23d
Cleared
Sep 29, 2011
NEODYNE DRESSING
MDA
Elastomer, Silicone, For Scar Management
65d
Cleared
Sep 29, 2011
MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
139d
Cleared
Sep 28, 2011
AURIGA XL
GEX
Powered Laser Surgical Instrument
124d
Cleared
Sep 26, 2011
HAIRMAX LASERCOMB
OAP
Laser, Comb, Hair
26d
Cleared
Sep 26, 2011
TEPHAFLEX MESH
OOD
Surgical Film
80d
Cleared
Sep 26, 2011
THE ESPINER SAC OR E SAC
GCJ
Laparoscope, General & Plastic Surgery
89d
Cleared
Sep 26, 2011
KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
221d
Cleared
Sep 23, 2011
CORELEADER COLLA-ALGI FIBER MODEL CAW
FRO
Dressing, Wound, Drug
108d
Cleared
Sep 22, 2011
CORELEADER SCAR-DIMMER
MDA
Elastomer, Silicone, For Scar Management
93d
Cleared
Sep 22, 2011
OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT
MNF
Implant, Temporal
157d
Cleared
Sep 20, 2011
CERALAS 147NM DIODE LASER SYSTEM
GEX
Powered Laser Surgical Instrument
46d
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