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
13866 General & Plastic Surgery devices
Cleared
Jun 09, 2008
PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE
NEW
Suture, Surgical, Absorbable, Polydioxanone
62d
Cleared
Jun 09, 2008
MOSAIC LASER SYSTEM
GEX
Powered Laser Surgical Instrument
68d
Cleared
Jun 09, 2008
WG-SURGICAL SUTURES WITH NEEDLE
GAP
Suture, Nonabsorbable, Silk
91d
Cleared
May 30, 2008
GORE INFINIT MESH
FTL
Mesh, Surgical, Polymeric
45d
Cleared
May 29, 2008
PALOMAR ASPIRE LASER PLATFORM
GEX
Powered Laser Surgical Instrument
9d
Cleared
May 29, 2008
PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR
GCJ
Laparoscope, General & Plastic Surgery
127d
Cleared
May 28, 2008
SURESKIN SILVER BANDAGES
FRO
Dressing, Wound, Drug
23d
Cleared
May 28, 2008
PROSTATE TISSUE MARKER
NEU
Marker, Radiographic, Implantable
34d
Cleared
May 28, 2008
PARIETEX PROGRIP MESH
FTL
Mesh, Surgical, Polymeric
44d
Cleared
May 28, 2008
THERABOND ANTIMICROBIAL BARRIER SYSTEMS
FRO
Dressing, Wound, Drug
196d
Cleared
May 23, 2008
AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR
GCJ
Laparoscope, General & Plastic Surgery
29d
Cleared
May 23, 2008
ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
231d
Cleared
May 23, 2008
ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
231d
Cleared
May 23, 2008
ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM
GEX
Powered Laser Surgical Instrument
255d
Cleared
May 22, 2008
MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS
GCJ
Laparoscope, General & Plastic Surgery
112d
Cleared
May 21, 2008
ECHELON GRAY CARTRIDGE, MODEL ERC45M
GDW
Staple, Implantable
57d
Cleared
May 21, 2008
SONOCA 180/195 WOUND CARE SYSTEM
LFL
Instrument, Ultrasonic Surgical
223d
Cleared
May 20, 2008
NEUTROPHASE
KMF
Bandage, Liquid
42d
Cleared
May 19, 2008
MODIFICATION TO 3M TEGADERM CHG DRESSING
FRO
Dressing, Wound, Drug
76d
Cleared
May 15, 2008
HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
52d
Cleared
May 15, 2008
COLLAGEN TENDON WRAP
FTM
Mesh, Surgical
86d
Cleared
May 15, 2008
BIOSYAG MEDICAL SYSTEM
GEX
Powered Laser Surgical Instrument
93d
Cleared
May 14, 2008
STYLA MICROLASER AND STYLAORTHO
GEX
Powered Laser Surgical Instrument
14d
Cleared
May 14, 2008
3 CCD ENDOCAM 5550
GCJ
Laparoscope, General & Plastic Surgery
37d
Cleared
May 14, 2008
SIALO BALLOON DILATATION CATHETER
GCJ
Laparoscope, General & Plastic Surgery
230d
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