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
14039 General & Plastic Surgery devices
Cleared
May 13, 1999
PULSEMASTER DENTAL LASER SYSTEM
GEX
Powered Laser Surgical Instrument
147d
Cleared
May 13, 1999
NOVUS VERDI DELIVERY SYSTEMS
GEX
Powered Laser Surgical Instrument
30d
Cleared
May 04, 1999
EDGE SYSTEMS STERILE TUBING
GEX
Powered Laser Surgical Instrument
57d
Cleared
Apr 30, 1999
SILK SUTURE
GAP
Suture, Nonabsorbable, Silk
260d
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 29, 1999
ORLIGHT 2000 SURGICAL LASER SYSTEM
GEX
Powered Laser Surgical Instrument
76d
Cleared
Apr 29, 1999
FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER
KMF
Bandage, Liquid
42d
Cleared
Apr 28, 1999
STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP
GAQ
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
160d
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 23, 1999
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
EFQ
Gauze/sponge, Internal
59d
Cleared
Apr 16, 1999
STRAUMANN EXTRAORAL IMPLANT SYSTEM
KCZ
Prosthesis, Breast, External, Used With Adhesive
63d
Cleared
Apr 14, 1999
NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS
MDA
Elastomer, Silicone, For Scar Management
141d
Cleared
Apr 14, 1999
DUMEX IODOFORM PACKING STRIP
FRO
Dressing, Wound, Drug
70d
Cleared
Apr 14, 1999
SMITH & NEPHEW HANDPORT SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
63d
Cleared
Apr 14, 1999
DERMACOOL
GEX
Powered Laser Surgical Instrument
63d
Cleared
Apr 12, 1999
WOUND DRESSING/ABD PAD, MODEL #10810
NAD
Dressing, Wound, Occlusive
27d
Cleared
Apr 08, 1999
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
GEX
Powered Laser Surgical Instrument
230d
Cleared
Apr 01, 1999
LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP)
GEX
Powered Laser Surgical Instrument
175d
Cleared
Apr 01, 1999
POINT SETTER
GCJ
Laparoscope, General & Plastic Surgery
115d
Cleared
Apr 01, 1999
ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
GCJ
Laparoscope, General & Plastic Surgery
86d
Cleared
Apr 01, 1999
ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IV
GEX
Powered Laser Surgical Instrument
72d
Cleared
Apr 01, 1999
INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1
GCJ
Laparoscope, General & Plastic Surgery
71d
Cleared
Apr 01, 1999
MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
10d
Cleared
Apr 01, 1999
NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
10d
Cleared
Mar 31, 1999
HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM
KGN
Wound Dressing With Animal-derived Material(s)
79d
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