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
13934 General & Plastic Surgery devices
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
Cleared
May 04, 2006
DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS
GEX
Powered Laser Surgical Instrument
247d
Cleared
Apr 28, 2006
SPECTRAGENICS ATS-1
GEX
Powered Laser Surgical Instrument
56d
Cleared
Apr 27, 2006
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA
GEH
Unit, Cryosurgical, Accessories
72d
Cleared
Apr 27, 2006
TULIP DISPOSABLE CANNULAS
QPB
System, Suction, Lipoplasty For Removal
105d
Cleared
Apr 27, 2006
STRYKER SCOPE/INSTRUMENT HOLDER
GCJ
Laparoscope, General & Plastic Surgery
106d
Cleared
Apr 27, 2006
VIVAWAVE MICROWAVE ABLATION SYSTEM
NEY
System, Ablation, Microwave And Accessories
129d
Cleared
Apr 25, 2006
NURSE ASSISTANT 1.7 O.R. CONTROL SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
39d
Cleared
Apr 21, 2006
SPRAYGENIX CRYO ABLATION SYSTEM
GEH
Unit, Cryosurgical, Accessories
50d
Cleared
Apr 21, 2006
BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F
GEI
Electrosurgical, Cutting & Coagulation & Accessories
88d
Cleared
Apr 19, 2006
MODIFICATION TO ENDOTINE RIBBON
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
23d
Cleared
Apr 18, 2006
COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING
FRO
Dressing, Wound, Drug
25d
Cleared
Apr 14, 2006
KELO-COTE SPRAY
MDA
Elastomer, Silicone, For Scar Management
121d
Cleared
Apr 13, 2006
SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
22d
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