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
14060 General & Plastic Surgery devices
Cleared
Dec 09, 1997
UAS ULTRASONIC ASPIRATOR SYSTEM
LFL
Instrument, Ultrasonic Surgical
223d
Cleared
Dec 09, 1997
VISTA HEAD MOUNTED DISPLAY
GCJ
Laparoscope, General & Plastic Surgery
90d
Cleared
Dec 09, 1997
TORNIER CEMENT RESTRICTOR
JDI
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
89d
Cleared
Dec 09, 1997
COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS
GEX
Powered Laser Surgical Instrument
88d
Cleared
Dec 09, 1997
EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
90d
Cleared
Dec 05, 1997
ETHICON NON-STICK BIPOLAR FORCEPS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
88d
Cleared
Dec 04, 1997
CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER
GEX
Powered Laser Surgical Instrument
133d
Cleared
Dec 04, 1997
SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)
GEX
Powered Laser Surgical Instrument
90d
Cleared
Dec 04, 1997
KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
KMF
Bandage, Liquid
79d
Cleared
Dec 04, 1997
JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
GBX
Catheter, Irrigation
69d
Cleared
Dec 03, 1997
STARLIGHT PULSED DIODE ARRAY LASER SYSTEM
GEX
Powered Laser Surgical Instrument
90d
Cleared
Dec 03, 1997
TWEEZER-TYPE EPILATOR
KCX
Epilator, High Frequency, Tweezer-type
89d
Cleared
Dec 02, 1997
CURVILINEAR SUTURE PLACEMENT SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
84d
Cleared
Dec 01, 1997
INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450
GBW
Catheter, Peritoneal
179d
Cleared
Dec 01, 1997
BIODERM FOAM WOUND DRESSING
KMF
Bandage, Liquid
82d
Cleared
Dec 01, 1997
ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING
MGP
Dressing, Wound And Burn, Occlusive
67d
Cleared
Dec 01, 1997
IT HYDROCOLLOID WITH ZINC
FRO
Dressing, Wound, Drug
53d
Cleared
Nov 26, 1997
ENDOASSIST
GCJ
Laparoscope, General & Plastic Surgery
89d
Cleared
Nov 26, 1997
MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM
BTA
Pump, Portable, Aspiration (manual Or Powered)
89d
Cleared
Nov 26, 1997
BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451
GEI
Electrosurgical, Cutting & Coagulation & Accessories
85d
Cleared
Nov 26, 1997
PIN CARE KIT
EFQ
Gauze/sponge, Internal
85d
Cleared
Nov 25, 1997
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
KMF
Bandage, Liquid
90d
Cleared
Nov 24, 1997
PANOVIEW PLUS TELESCOPE, 3.5MM, O,WL 300MM/25,WL 300MM/0,WL 180MM
GCJ
Laparoscope, General & Plastic Surgery
77d
Cleared
Nov 24, 1997
SOFTFORM FACIAL IMPLANT
FTL
Mesh, Surgical, Polymeric
73d
Cleared
Nov 21, 1997
DOW CORNING SILASTIC ELASTOMER Q7-4750
MIB
Elastomer, Silicone Block
88d
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