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
7705 General & Plastic Surgery devices
Cleared
Jul 20, 1999
CICACARE MANAGEMENT FOR SCARS
MDA
Elastomer, Silicone, For Scar Management
40d
Cleared
Jul 12, 1999
OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP
GEX
Powered Laser Surgical Instrument
10d
Cleared
Jul 12, 1999
CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASER
GEX
Powered Laser Surgical Instrument
21d
Cleared
Jul 12, 1999
PARIETENE POLYPROPYLENE MESH
FTL
Mesh, Surgical, Polymeric
81d
Cleared
Jul 12, 1999
TROCAR SYSTEM ACCORDING TO HASSON
GCJ
Laparoscope, General & Plastic Surgery
169d
Cleared
Jun 25, 1999
MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS
GCJ
Laparoscope, General & Plastic Surgery
17d
Cleared
Jun 23, 1999
DEXIDE BIPOLAR FORCEPS II ** DEVICE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
22d
Cleared
Jun 23, 1999
MULTACHOICE INSTRUMENTS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
27d
Cleared
Jun 23, 1999
DCI ENDOSCOPE
GCJ
Laparoscope, General & Plastic Surgery
72d
Cleared
Jun 23, 1999
DCI ENDOSCOPE
GCJ
Laparoscope, General & Plastic Surgery
77d
Cleared
Jun 22, 1999
ENDOPATH ENDOSCOPIC INSTRUMENTS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
207d
Cleared
Jun 15, 1999
CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX
GEI
Electrosurgical, Cutting & Coagulation & Accessories
14d
Cleared
Jun 04, 1999
MODIFICATION TO WOUN'DRES
MGQ
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
74d
Cleared
May 27, 1999
STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
8d
Cleared
May 18, 1999
SIGNADRESS DUODERM DRESSING
KGN
Wound Dressing With Animal-derived Material(s)
56d
Cleared
May 17, 1999
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
GDW
Staple, Implantable
49d
Cleared
May 17, 1999
CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
83d
Cleared
May 13, 1999
NOVUS VERDI DELIVERY SYSTEMS
GEX
Powered Laser Surgical Instrument
30d
Cleared
Apr 30, 1999
ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC
GAL
Suture, Absorbable, Natural
18d
Cleared
Apr 30, 1999
SILK SUTURE
GAP
Suture, Nonabsorbable, Silk
260d
Cleared
Apr 27, 1999
MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH, HO: YAG/ND: YAG SURGICAL LASERS AND DELIVERY
GEX
Powered Laser Surgical Instrument
36d
Cleared
Apr 16, 1999
STRAUMANN EXTRAORAL IMPLANT SYSTEM
KCZ
Prosthesis, Breast, External, Used With Adhesive
63d
Cleared
Apr 14, 1999
SMITH & NEPHEW HANDPORT SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
63d
Cleared
Apr 01, 1999
NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
10d
Cleared
Apr 01, 1999
MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
10d
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