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
Aug 29, 2013
ENDOWRIST ONE VESSEL SEALER
NAY
System, Surgical, Computer Controlled Instrument
206d
Cleared
Aug 22, 2013
ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND
GEI
Electrosurgical, Cutting & Coagulation & Accessories
45d
Cleared
Aug 22, 2013
SYMBOTEX(TM) COMPOSITE MESH
FTL
Mesh, Surgical, Polymeric
55d
Cleared
Aug 09, 2013
ARTHROCARE HEAD AND NECK COBLATION WAND
GEI
Electrosurgical, Cutting & Coagulation & Accessories
102d
Cleared
Aug 09, 2013
ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
KCY
Tourniquet, Pneumatic
263d
Cleared
Aug 01, 2013
PASSPORT ROBOTIC REDUCER CAP
GCJ
Laparoscope, General & Plastic Surgery
128d
Cleared
Jul 31, 2013
ARTHREX SPEEDCINCH
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
29d
Cleared
Jul 30, 2013
DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES
NAY
System, Surgical, Computer Controlled Instrument
344d
Cleared
Jul 19, 2013
TRANSCEND
GEI
Electrosurgical, Cutting & Coagulation & Accessories
514d
Cleared
Jul 03, 2013
CYBER TM FAMILY
GEX
Powered Laser Surgical Instrument
76d
Cleared
Jul 02, 2013
MDK MULTI-APPLICATIONS PLATFORM
GEX
Powered Laser Surgical Instrument
151d
Cleared
Jul 02, 2013
ARTHROCARE TURBINATOR WAND
GEI
Electrosurgical, Cutting & Coagulation & Accessories
305d
Cleared
Jul 01, 2013
COOK HOLMIUM LASER FIBER
GEX
Powered Laser Surgical Instrument
185d
Cleared
Jun 07, 2013
DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK
NAY
System, Surgical, Computer Controlled Instrument
81d
Cleared
May 22, 2013
H-30 HOLMIUM LASER SYSTEM
GEX
Powered Laser Surgical Instrument
90d
Cleared
May 17, 2013
AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE
MPN
Tissue Adhesive For The Topical Approximation Of Skin
316d
Cleared
May 14, 2013
ATRICLIP GILLINOV-COSGROVE LAA CLIP
FZP
Clip, Implantable
25d
Cleared
May 01, 2013
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
FTL
Mesh, Surgical, Polymeric
23d
Cleared
Apr 17, 2013
PLASMATRODE SALINE SAFE TUR ELECTRODE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
224d
Cleared
Apr 15, 2013
YOULASER CO2 LASER
GEX
Powered Laser Surgical Instrument
146d
Cleared
Apr 11, 2013
MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS
LCJ
Tissue Expander And Accessories
17d
Cleared
Apr 11, 2013
SHORT PORT BLUNT TIP TROCAR
GCJ
Laparoscope, General & Plastic Surgery
84d
Cleared
Apr 05, 2013
ACCUMESH DEPLOYMENT SYSTEM
ORQ
Mesh, Surgical, Deployer
15d
Cleared
Apr 05, 2013
LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
GEI
Electrosurgical, Cutting & Coagulation & Accessories
17d
Cleared
Apr 05, 2013
OLYMPUS ENERGY POWER SYSTEM (EPS)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
149d
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