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
13946 General & Plastic Surgery devices
Cleared
Jun 27, 2005
REVLIGHT SKIN CARE SYSTEM
GEX
Powered Laser Surgical Instrument
273d
Cleared
Jun 27, 2005
CYNERGY MULTIPLEX LASER
GEX
Powered Laser Surgical Instrument
91d
Cleared
Jun 23, 2005
ENDOTINE RIBBON
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
22d
Cleared
Jun 17, 2005
WHS-1000 WOUND HEALING SYSTEM
KPJ
Chamber, Oxygen, Topical, Extremity
144d
Cleared
Jun 17, 2005
AMS COLLAGEN DERMAL MATRIX
PAG
Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
115d
Cleared
Jun 17, 2005
MEDLITE C1 Q-SWITCHED ND:YAG LASER
GEX
Powered Laser Surgical Instrument
91d
Cleared
Jun 15, 2005
BIODERM SCIENCES WOUND HEALING SPRAY
FRO
Dressing, Wound, Drug
316d
Cleared
Jun 13, 2005
SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC
FRO
Dressing, Wound, Drug
91d
Cleared
Jun 13, 2005
CANDELA FAMILY OF PULSE DYE LASER SYSTEMS
GEX
Powered Laser Surgical Instrument
90d
Cleared
Jun 09, 2005
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
FRO
Dressing, Wound, Drug
302d
Cleared
Jun 09, 2005
VELASMOOTH, SHAPER
NUV
Massager, Vacuum, Light Induced Heating
113d
Cleared
Jun 08, 2005
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
FZP
Clip, Implantable
36d
Cleared
Jun 06, 2005
COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING
FRO
Dressing, Wound, Drug
189d
Cleared
Jun 06, 2005
REPROCESSED ULTRASONIC SCALPELS
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
182d
Cleared
Jun 06, 2005
AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
LFL
Instrument, Ultrasonic Surgical
70d
Cleared
Jun 03, 2005
TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
361d
Cleared
Jun 03, 2005
TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE
GAP
Suture, Nonabsorbable, Silk
361d
Cleared
Jun 03, 2005
HEMCON BANDAGE AND HEMCON BANDAGE OTC
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
211d
Cleared
Jun 03, 2005
OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG
LFL
Instrument, Ultrasonic Surgical
57d
Cleared
Jun 02, 2005
TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE
GAR
Suture, Nonabsorbable, Synthetic, Polyamide
360d
Cleared
Jun 02, 2005
NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
360d
Cleared
Jun 02, 2005
FT FIBER OPTIC DELIVERY SYSTEMS
GEX
Powered Laser Surgical Instrument
77d
Cleared
Jun 02, 2005
HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P
LFL
Instrument, Ultrasonic Surgical
38d
Cleared
Jun 01, 2005
ZENO
GEX
Powered Laser Surgical Instrument
175d
Cleared
Jun 01, 2005
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
47d
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