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
13744 General & Plastic Surgery devices
Cleared
Apr 17, 2014
LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
49d
Cleared
Apr 17, 2014
NEOV DIODE LASER FAMILY
GEX
Powered Laser Surgical Instrument
204d
Cleared
Apr 17, 2014
ADVATX
GEX
Powered Laser Surgical Instrument
206d
Cleared
Apr 17, 2014
DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES
NAY
System, Surgical, Computer Controlled Instrument
294d
Cleared
Apr 15, 2014
FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER
GEX
Powered Laser Surgical Instrument
47d
Cleared
Apr 14, 2014
CABOCHON SYSTEM
OUP
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
105d
Cleared
Apr 14, 2014
AVANCE® FOAM ABDOMINAL DRESSING KIT
OXJ
Mesh, Surgical, Non-absorbable, Large Abdominal Wall Defects
382d
Cleared
Apr 11, 2014
REVEEL ENDOSCOPIC RETRACTOR
GCJ
Laparoscope, General & Plastic Surgery
163d
Cleared
Apr 10, 2014
REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
140d
Cleared
Apr 10, 2014
CONTOUR I V3.1 SYSTEM
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
171d
Cleared
Apr 09, 2014
RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS
GDW
Staple, Implantable
30d
Cleared
Apr 09, 2014
VIORA V-TOTAL
GEX
Powered Laser Surgical Instrument
112d
Cleared
Apr 09, 2014
ZELTIQ COOLSCULPTING SYSTEM
OOK
Dermal Cooling Pack/vacuum/massager
173d
Cleared
Apr 09, 2014
SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM
GDW
Staple, Implantable
314d
Cleared
Apr 08, 2014
SURGICAL LIGHT HANDLE COVER
FTA
Light, Surgical, Accessories
140d
Cleared
Apr 04, 2014
AFTAMED MOUTHWASH
OLR
Oral Wound Dressing
364d
Cleared
Apr 03, 2014
MACH LED 2MC
FSY
Light, Surgical, Ceiling Mounted
38d
Cleared
Apr 03, 2014
MACH LED 2SC
FSY
Light, Surgical, Ceiling Mounted
38d
Cleared
Apr 03, 2014
PERCLOT TOPICAL
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
269d
Not Cleared
Apr 03, 2014
XSTAT
PGZ
Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
428d
Cleared
Mar 31, 2014
ICEROD CX CRYOABLATION NEEDLE
GEH
Unit, Cryosurgical, Accessories
24d
Cleared
Mar 31, 2014
MIROMATRIX BIOLOGICAL MESH
FTM
Mesh, Surgical
90d
Cleared
Mar 31, 2014
VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)
FRO
Dressing, Wound, Drug
283d
Cleared
Mar 28, 2014
DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
NAY
System, Surgical, Computer Controlled Instrument
277d
Cleared
Mar 26, 2014
MONOTEX
NBY
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
36d
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