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 05, 2013
CIQ CONTROLLER, CIQ WANDS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
156d
Cleared
Apr 05, 2013
HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY
MTJ
Wax, Bone
170d
Cleared
Apr 04, 2013
PHANTOM FIBER BIOFIBER SUTURE
NWJ
Suture, Recombinant Technology
43d
Cleared
Mar 29, 2013
ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
GDW
Staple, Implantable
17d
Cleared
Mar 29, 2013
CELLULAZE LASER
OYW
Laser, Cellulite Appearance
144d
Cleared
Mar 26, 2013
VENACURE EVLT NEVERTOUCH PROCEDURE KIT
GEX
Powered Laser Surgical Instrument
14d
Cleared
Mar 22, 2013
CAIMAN SEAL AND CUT TECHNOLOGY
GEI
Electrosurgical, Cutting & Coagulation & Accessories
15d
Cleared
Mar 21, 2013
DORNIER MEDILAS UROPULSE
GEX
Powered Laser Surgical Instrument
38d
Cleared
Mar 08, 2013
ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS
PDG
Electrosurgical Vessel And/or Tissue Sealer. With Built-in Generator.
144d
Cleared
Feb 28, 2013
EDRAIN CHEST DRAINAGE SYSTEM
BTA
Pump, Portable, Aspiration (manual Or Powered)
41d
Cleared
Feb 28, 2013
3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
FRO
Dressing, Wound, Drug
90d
Cleared
Feb 14, 2013
CONNECT FOR DA VINCI SURGICAL SYSTEM(S)
NAY
System, Surgical, Computer Controlled Instrument
63d
Cleared
Feb 08, 2013
ALEXIS O WOUND PROTECTOR/RETRACTOR
KGW
Ring (wound Protector), Drape Retention, Internal
462d
Cleared
Feb 05, 2013
ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE
GDW
Staple, Implantable
125d
Cleared
Feb 01, 2013
DORNIER MEDILAS H30 SOLVO
GEX
Powered Laser Surgical Instrument
196d
Cleared
Jan 28, 2013
ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY
MTJ
Wax, Bone
192d
Cleared
Jan 25, 2013
REPROCESSED VESSEL SEALER
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
115d
Cleared
Jan 25, 2013
ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW
GEI
Electrosurgical, Cutting & Coagulation & Accessories
135d
Cleared
Jan 23, 2013
FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
90d
Cleared
Jan 22, 2013
PERMASORB DISPOSABLE FIXATION DEVICE
GDW
Staple, Implantable
49d
Cleared
Jan 10, 2013
SENOMARK ULTRA BREAST TISSUE MARKER
NEU
Marker, Radiographic, Implantable
22d
Cleared
Jan 03, 2013
SOVEREIGN MINI
GCJ
Laparoscope, General & Plastic Surgery
93d
Cleared
Dec 21, 2012
DETACHATIP III
GEI
Electrosurgical, Cutting & Coagulation & Accessories
64d
Cleared
Dec 20, 2012
Q-PLUS T+ IPL LASER SYSTEM
GEX
Powered Laser Surgical Instrument
72d
Cleared
Dec 18, 2012
AESCULAP NOVOSYN ABSORBABLE SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
103d
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