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
7639 General & Plastic Surgery devices
Cleared
Aug 06, 2010
ENDOSCOPIC CLIP SYSTEM
FZP
Clip, Implantable
11d
Cleared
Aug 06, 2010
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
OMP
Negative Pressure Wound Therapy Powered Suction Pump
22d
Cleared
Jul 30, 2010
ARTHREX BIOWIRE
GAS
Suture, Nonabsorbable, Synthetic, Polyester
477d
Cleared
Jul 22, 2010
QUANTA DIODE LASER SYSTEM
GEX
Powered Laser Surgical Instrument
143d
Cleared
Jul 16, 2010
ERBE ESU MODEL VIO 100 C WITH ACCESSORIES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
87d
Cleared
Jul 14, 2010
AESCULAP MONOMAX ABSORBABLE SUTURE
NWJ
Suture, Recombinant Technology
106d
Cleared
Jul 01, 2010
PK SUPERPULSE SYSEM GENERATOR MODEL 744000
GEI
Electrosurgical, Cutting & Coagulation & Accessories
100d
Cleared
Jun 25, 2010
SINGLE SITE FLEXIBLE BLADELESS OBTURATOR
GCJ
Laparoscope, General & Plastic Surgery
11d
Cleared
Jun 25, 2010
STRYKER KNIFELIGHT
FTD
Lamp, Surgical
87d
Cleared
Jun 18, 2010
VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214
GEI
Electrosurgical, Cutting & Coagulation & Accessories
105d
Cleared
Jun 17, 2010
GYRUS ACMI HALO PKS CUTTING FORCEPS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
78d
Cleared
Jun 10, 2010
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0
FZP
Clip, Implantable
195d
Cleared
May 21, 2010
CONMED MACROLYTE DISPERSIVE ELECTRODE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
72d
Cleared
May 14, 2010
SUREFIT DUAL DISPERSIVE ELECTRODE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
126d
Cleared
May 13, 2010
SPINEWAND SURGICAL DEVICE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
90d
Cleared
May 12, 2010
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
244d
Cleared
May 05, 2010
PARIE TENE PROGRIP MESH
FTL
Mesh, Surgical, Polymeric
7d
Cleared
May 04, 2010
DERMABOND NX ADHESIVE MODEL: DNX6, DNX12
MPN
Tissue Adhesive For The Topical Approximation Of Skin
77d
Cleared
Apr 22, 2010
SPECIMEN RETRIEVAL SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
15d
Cleared
Apr 22, 2010
TORNIER SURGICAL MESH
FTL
Mesh, Surgical, Polymeric
133d
Cleared
Apr 21, 2010
VENTRIO HERNIA PATCH
FTL
Mesh, Surgical, Polymeric
85d
Cleared
Apr 07, 2010
HARMONIC FOCUS SHEARS
LFL
Instrument, Ultrasonic Surgical
36d
Cleared
Apr 07, 2010
ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
GDW
Staple, Implantable
113d
Cleared
Apr 02, 2010
ALEXIS ORTHOPAEDIC WOUND RETRACTOR
KGW
Ring (wound Protector), Drape Retention, Internal
77d
Cleared
Mar 17, 2010
HARMONY VLED SURGICAL LIGHTNING SYSTEM
FST
Light, Surgical, Fiberoptic
29d
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