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
14076 General & Plastic Surgery devices
Cleared
Apr 24, 1997
FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERS
GEX
Powered Laser Surgical Instrument
202d
Cleared
Apr 24, 1997
(FSI) LAPAROSCOPIC PROBE FOR ALL FSI ULE FF101 FIBERS. MODEL FSI FF101-LP-XXX, WHERE XXX = FIBER DIAMETERS 100, 200, 400
GEX
Powered Laser Surgical Instrument
202d
Cleared
Apr 23, 1997
KENDALL HYDROPHILIC POWDER WOUND DRESSING
KGN
Wound Dressing With Animal-derived Material(s)
90d
Cleared
Apr 23, 1997
SMITH & NEPHEW MIS INSTRUMENTS
GCJ
Laparoscope, General & Plastic Surgery
40d
Cleared
Apr 23, 1997
QA-ES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
28d
Cleared
Apr 22, 1997
RONIX II ROTARY ULTRASONIC SURGICAL SYSTEM
LFL
Instrument, Ultrasonic Surgical
147d
Cleared
Apr 21, 1997
ACUFEX DOUBLE ARMED SUTURE NEEDLE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
76d
Cleared
Apr 21, 1997
RIGHT ANGLE LASER FIBERS
GEX
Powered Laser Surgical Instrument
77d
Cleared
Apr 21, 1997
INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP
GCJ
Laparoscope, General & Plastic Surgery
49d
Cleared
Apr 17, 1997
RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)
GEX
Powered Laser Surgical Instrument
153d
Cleared
Apr 16, 1997
STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOW
GEI
Electrosurgical, Cutting & Coagulation & Accessories
216d
Cleared
Apr 16, 1997
PROXIDERM (D-460,D 90 460,D 180,460, PS 460)
MKY
System, Skin Closure
70d
Cleared
Apr 16, 1997
HANAULUX BLUE 80 HOSPITAL
FSS
Light, Surgical, Floor Standing
69d
Cleared
Apr 16, 1997
CABLE HOLDER, SUCTION TUBE HOLDER
GEI
Electrosurgical, Cutting & Coagulation & Accessories
26d
Cleared
Apr 14, 1997
ARTHROCARE DERMATOLOGIC ELECTROSURGERY SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
132d
Cleared
Apr 14, 1997
AMERIGEL OINTMENT
MGQ
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
89d
Cleared
Apr 14, 1997
3 DIMENSIONAL VIDEO ENDOSCOPE
GCJ
Laparoscope, General & Plastic Surgery
83d
Cleared
Apr 14, 1997
VISTA MINI CAMERA SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
73d
Cleared
Apr 11, 1997
VENISECT LASER LANCET
GEX
Powered Laser Surgical Instrument
486d
Cleared
Apr 11, 1997
DERMA 20 LASER SYSTEM
GEX
Powered Laser Surgical Instrument
169d
Cleared
Apr 11, 1997
OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
84d
Cleared
Apr 11, 1997
B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING
MGQ
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
79d
Cleared
Apr 09, 1997
OTOSILK OTOLOGICAL GRAFT DRESSING
NAD
Dressing, Wound, Occlusive
148d
Cleared
Apr 09, 1997
SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
55d
Cleared
Apr 07, 1997
AESOP SYSTEM AND ACCESSORIES
GCJ
Laparoscope, General & Plastic Surgery
238d
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