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
137d
Avg (2y)
1976
Since
7711 General & Plastic Surgery devices
Cleared
May 21, 1997
UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
203d
Cleared
May 15, 1997
QUANTUM 3080SP SURGICAL TABLE
GDC
Table, Operating-room, Electrical
31d
Cleared
May 13, 1997
MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
41d
Cleared
May 05, 1997
STANDARD & EXTENDED BLADE/NEEDLE/BALL
JOS
Electrode, Electrosurgical
34d
Cleared
May 05, 1997
MODIFIED USSC* POLYSORB SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
56d
Cleared
May 05, 1997
ANSPACH LUBRICATING SYSTEM II
GEY
Motor, Surgical Instrument, Ac-powered
82d
Cleared
May 02, 1997
BONE SOURCE HYDROXYAPATITE
LZK
Implant, Malar
88d
Cleared
Apr 25, 1997
MODIFIED E-PACK PROCEDURE KIT
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
88d
Cleared
Apr 23, 1997
KENDALL HYDROPHILIC POWDER WOUND DRESSING
KGN
Wound Dressing With Animal-derived Material(s)
90d
Cleared
Apr 21, 1997
RIGHT ANGLE LASER FIBERS
GEX
Powered Laser Surgical Instrument
77d
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 14, 1997
ARTHROCARE DERMATOLOGIC ELECTROSURGERY SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
132d
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 11, 1997
OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
84d
Cleared
Apr 09, 1997
OTOSILK OTOLOGICAL GRAFT DRESSING
NAD
Dressing, Wound, Occlusive
148d
Cleared
Apr 07, 1997
LASERSCOPE AUTOMATIC EYE PROTECTION FILTER
GEX
Powered Laser Surgical Instrument
81d
Cleared
Mar 28, 1997
AESCULAP MODULAR MONOPOLAR ELECTRODES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
44d
Cleared
Mar 28, 1997
E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH
GEI
Electrosurgical, Cutting & Coagulation & Accessories
72d
Cleared
Mar 21, 1997
DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
MCY
Wound Dressing Kit
22d
Cleared
Mar 18, 1997
NIDEK CYBERSCAN
GEX
Powered Laser Surgical Instrument
75d
Cleared
Mar 17, 1997
EMERGENCY RELIEF KIT SYSTEM
LRR
First Aid Kit With Drug
161d
Cleared
Mar 17, 1997
CPC PROBE
GEX
Powered Laser Surgical Instrument
341d
Cleared
Mar 11, 1997
PROXIMATE DISPOSABLE SKIN STAPLER
GAG
Stapler, Surgical
61d
Cleared
Mar 11, 1997
FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
112d
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