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
7650 General & Plastic Surgery devices
Cleared
Jul 14, 2006
PDS PLUS ANTIBACTERIAL SUTURE
NEW
Suture, Surgical, Absorbable, Polydioxanone
91d
Cleared
Jul 11, 2006
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
OMP
Negative Pressure Wound Therapy Powered Suction Pump
15d
Cleared
Jul 03, 2006
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS
GDW
Staple, Implantable
68d
Cleared
Jun 19, 2006
MEDLINE COLLAGEN WOUND DRESSING
KGN
Wound Dressing With Animal-derived Material(s)
117d
Cleared
Jun 19, 2006
3M LIQUID BANDAGE
KMF
Bandage, Liquid
194d
Cleared
Jun 12, 2006
ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
GEX
Powered Laser Surgical Instrument
46d
Cleared
May 31, 2006
AUTO SUTUR ENDO GIA STAPLERS
GDW
Staple, Implantable
42d
Cleared
May 26, 2006
LAPARO-THORACO VIDEOSCOPE XLTF-VAW
GCJ
Laparoscope, General & Plastic Surgery
172d
Cleared
May 25, 2006
PROCEED SURGICAL MESH
FTL
Mesh, Surgical, Polymeric
69d
Cleared
May 24, 2006
PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT
GEX
Powered Laser Surgical Instrument
356d
Cleared
May 18, 2006
INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214
NAY
System, Surgical, Computer Controlled Instrument
13d
Cleared
May 18, 2006
MODIFICATION TO ARTHROCARE PERC-D SPINEWAND
GEI
Electrosurgical, Cutting & Coagulation & Accessories
13d
Cleared
May 17, 2006
DEKNA-LOK MODEL BP1000V2L
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
54d
Cleared
May 05, 2006
RELIENT NAVIGATION DEVICE
KAM
Cannula, Sinus
25d
Cleared
Apr 27, 2006
STRYKER SCOPE/INSTRUMENT HOLDER
GCJ
Laparoscope, General & Plastic Surgery
106d
Cleared
Apr 13, 2006
SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
22d
Cleared
Apr 10, 2006
ARTHROCARE WANDS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
14d
Cleared
Apr 10, 2006
INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182
NAY
System, Surgical, Computer Controlled Instrument
54d
Cleared
Apr 10, 2006
BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105
FTM
Mesh, Surgical
228d
Cleared
Apr 07, 2006
GELPORT BLUNT TIP TROCAR SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
29d
Cleared
Apr 07, 2006
HARMONIC SCALPEL BLADES AND SHEARS
LFL
Instrument, Ultrasonic Surgical
66d
Cleared
Apr 07, 2006
LIGHTSHEER DUET LASER SYSTEM
GEX
Powered Laser Surgical Instrument
99d
Cleared
Mar 31, 2006
ATRIUM MEDICAL CORPORATION C-QUR MESH
FTL
Mesh, Surgical, Polymeric
416d
Cleared
Mar 28, 2006
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
GAR
Suture, Nonabsorbable, Synthetic, Polyamide
28d
Cleared
Mar 16, 2006
ERBE VIO ESU, MODEL VIO 300 D
GEI
Electrosurgical, Cutting & Coagulation & Accessories
20d
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