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
13940 General & Plastic Surgery devices
Cleared
Nov 28, 2005
QUILL NONABSORBABLE NYLON BARBED SUTURE
GAR
Suture, Nonabsorbable, Synthetic, Polyamide
45d
Cleared
Nov 23, 2005
THROMBIX 3X3 HEMOSTATIC PAD
QSX
Hemostatic Wound Dressing With Thrombin Or Other Biologics
23d
Cleared
Nov 23, 2005
SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
299d
Cleared
Nov 22, 2005
SOPRANO HAIR REMOVAL DIODE LASER
GEX
Powered Laser Surgical Instrument
41d
Cleared
Nov 21, 2005
MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY
GEI
Electrosurgical, Cutting & Coagulation & Accessories
54d
Cleared
Nov 18, 2005
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA
GEH
Unit, Cryosurgical, Accessories
65d
Cleared
Nov 18, 2005
UVBIOTEK MODELS 3200B AND 4000B
FTC
Light, Ultraviolet, Dermatological
182d
Cleared
Nov 15, 2005
MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000
GEH
Unit, Cryosurgical, Accessories
35d
Cleared
Nov 15, 2005
NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES
GEX
Powered Laser Surgical Instrument
62d
Cleared
Nov 09, 2005
GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR
GEI
Electrosurgical, Cutting & Coagulation & Accessories
251d
Cleared
Nov 08, 2005
FORTADERM ANTIMICROBIAL WOUND DRESSING
FRO
Dressing, Wound, Drug
140d
Cleared
Nov 08, 2005
MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)
KMF
Bandage, Liquid
195d
Cleared
Nov 07, 2005
POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS
GDW
Staple, Implantable
21d
Cleared
Nov 07, 2005
MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
62d
Cleared
Nov 04, 2005
PIONEER U601 SERIES ASPIRATOR
BTA
Pump, Portable, Aspiration (manual Or Powered)
39d
Cleared
Nov 04, 2005
CALF IMPLANT, MODEL EC17-X
MIB
Elastomer, Silicone Block
52d
Cleared
Nov 04, 2005
GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
MIB
Elastomer, Silicone Block
52d
Cleared
Nov 04, 2005
MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM
OMP
Negative Pressure Wound Therapy Powered Suction Pump
58d
Cleared
Nov 04, 2005
MILTEX LIGATING CLIP
FZP
Clip, Implantable
101d
Cleared
Oct 31, 2005
1125 XSB XENON FIBER-OPTIC LIGHT SOURCE
HBI
Illuminator, Fiberoptic, Surgical Field
7d
Cleared
Oct 31, 2005
PATHFORMER
NWF
Drill, Battery Powered, Subungual Hematoma
31d
Cleared
Oct 25, 2005
ATRICURE TRANSPOLAR SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
11d
Cleared
Oct 25, 2005
AQUAMANTYS PUMP GENERATOR SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
14d
Cleared
Oct 25, 2005
GYRUS PLASMACISION AND PLASMABLEND ELECTRODES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
244d
Cleared
Oct 24, 2005
ALUMA SKIN RENEWAL SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
165d
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