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
13849 General & Plastic Surgery devices
Cleared
May 05, 2009
ORTHADAPT PR
FTL
Mesh, Surgical, Polymeric
89d
Cleared
May 04, 2009
COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
25d
Cleared
May 04, 2009
LUME 2 SYSTEM, MODEL GA0005000
GEX
Powered Laser Surgical Instrument
139d
Cleared
May 01, 2009
MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
15d
Cleared
May 01, 2009
MONTERIS MEDICAL AUTOLITT LASER PROBE
GEX
Powered Laser Surgical Instrument
337d
Cleared
Apr 29, 2009
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001
FZP
Clip, Implantable
20d
Cleared
Apr 29, 2009
GENADYNE A4-XLR8 WOUND VACUUM SYSTEM
OMP
Negative Pressure Wound Therapy Powered Suction Pump
50d
Cleared
Apr 28, 2009
ORTHOSTAT
MTJ
Wax, Bone
11d
Cleared
Apr 28, 2009
MTA PROTECTIVE SHEET
FTM
Mesh, Surgical
36d
Cleared
Apr 28, 2009
HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
180d
Cleared
Apr 23, 2009
FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY
GEX
Powered Laser Surgical Instrument
115d
Cleared
Apr 23, 2009
REBOUND HRDV
FTL
Mesh, Surgical, Polymeric
150d
Cleared
Apr 22, 2009
MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
7d
Cleared
Apr 22, 2009
PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)
FWP
Prosthesis, Chin, Internal
13d
Cleared
Apr 22, 2009
INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
FST
Light, Surgical, Fiberoptic
100d
Cleared
Apr 21, 2009
MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
FZP
Clip, Implantable
22d
Cleared
Apr 17, 2009
VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM
MVR
Device, Anastomotic, Microvascular
32d
Cleared
Apr 17, 2009
ISKRA MEDICAL GREEN IRF PRESTIGE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
134d
Cleared
Apr 16, 2009
PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS
GCJ
Laparoscope, General & Plastic Surgery
38d
Cleared
Apr 16, 2009
SILVER WOUND PAD
FRO
Dressing, Wound, Drug
127d
Cleared
Apr 14, 2009
CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C
GEX
Powered Laser Surgical Instrument
36d
Cleared
Apr 14, 2009
BLUESHINE GOLD SERIES
GEX
Powered Laser Surgical Instrument
67d
Cleared
Apr 14, 2009
ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM
GEX
Powered Laser Surgical Instrument
111d
Cleared
Apr 10, 2009
AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS
GDW
Staple, Implantable
135d
Cleared
Apr 08, 2009
QUIKCLOT INTEVENTIONAL, MODEL P/N 182
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
30d
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