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
13897 General & Plastic Surgery devices
Cleared
May 25, 2006
VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
FTC
Light, Ultraviolet, Dermatological
16d
Cleared
May 25, 2006
ACMI DUR-HL LASER SYSTEMS
GEX
Powered Laser Surgical Instrument
65d
Cleared
May 25, 2006
PROCEED SURGICAL MESH
FTL
Mesh, Surgical, Polymeric
69d
Cleared
May 24, 2006
MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523
GEX
Powered Laser Surgical Instrument
44d
Cleared
May 24, 2006
PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT
GEX
Powered Laser Surgical Instrument
356d
Cleared
May 22, 2006
CRYOSHAPE
GEH
Unit, Cryosurgical, Accessories
48d
Cleared
May 19, 2006
MANI NEEDLE & SUTURE PACK (SILK)
GAP
Suture, Nonabsorbable, Silk
141d
Cleared
May 19, 2006
MANI NEEDLE & SUTURE PACK (NYLON)
GAR
Suture, Nonabsorbable, Synthetic, Polyamide
141d
Cleared
May 18, 2006
INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214
NAY
System, Surgical, Computer Controlled Instrument
13d
Cleared
May 18, 2006
MODIFICATION TO ARTHROCARE PERC-D SPINEWAND
GEI
Electrosurgical, Cutting & Coagulation & Accessories
13d
Cleared
May 18, 2006
TRABECTOME HIGH FREQUENCY GENERATOR/LP
GEI
Electrosurgical, Cutting & Coagulation & Accessories
13d
Cleared
May 17, 2006
XENFORM SOFT TISSUE REPAIR MATRIX
FTM
Mesh, Surgical
37d
Cleared
May 17, 2006
COSMATRIX
FTM
Mesh, Surgical
51d
Cleared
May 17, 2006
DEKNA-LOK MODEL BP1000V2L
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
54d
Cleared
May 17, 2006
HEMOHALT HEMOSTASIS PAD
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
90d
Cleared
May 17, 2006
MIDIVIEW SERIES OF MICROENDOSCOPES
GCJ
Laparoscope, General & Plastic Surgery
386d
Cleared
May 17, 2006
EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS
FRO
Dressing, Wound, Drug
495d
Cleared
May 15, 2006
TISSUEMEND SOFT TISSUE REPAIR MATRIX
FTM
Mesh, Surgical
35d
Cleared
May 15, 2006
ELLIPSE 12PL, MODEL 9ESL7228
GEX
Powered Laser Surgical Instrument
77d
Cleared
May 12, 2006
SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
226d
Cleared
May 10, 2006
ORAMAGIC PLUS ORAL WOUND RINSE
OLR
Oral Wound Dressing
89d
Cleared
May 10, 2006
SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
224d
Cleared
May 10, 2006
SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
224d
Cleared
May 09, 2006
BIOBLANKET SURGICAL MESH
FTM
Mesh, Surgical
25d
Cleared
May 05, 2006
RELIENT NAVIGATION DEVICE
KAM
Cannula, Sinus
25d
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