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
13830 General & Plastic Surgery devices
Cleared
Jun 29, 2011
MAX ORIENT SUCTION DEVICE FOR ELECTROCAUTERIZER
GEI
Electrosurgical, Cutting & Coagulation & Accessories
14d
Cleared
Jun 28, 2011
BIPOLAR HF DEVICE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
106d
Cleared
Jun 28, 2011
MEDART DIODE LASER SYSTEM & ACCESSORIES
GEX
Powered Laser Surgical Instrument
152d
Cleared
Jun 28, 2011
HALIFAX BIOMEDICAL TANATLUM BEAD SET
NEU
Marker, Radiographic, Implantable
218d
Cleared
Jun 23, 2011
SOUND SURGICAL VASER 2.1 LIPO SYSTEM
QPB
System, Suction, Lipoplasty For Removal
141d
Cleared
Jun 22, 2011
PALOMAR ICON (TM) AESTHETIC SYSTEM
GEX
Powered Laser Surgical Instrument
83d
Cleared
Jun 22, 2011
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD
OMP
Negative Pressure Wound Therapy Powered Suction Pump
107d
Cleared
Jun 22, 2011
CUTERA QSWITCH LASER SYSTEM
GEX
Powered Laser Surgical Instrument
260d
Cleared
Jun 21, 2011
ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE
GEH
Unit, Cryosurgical, Accessories
78d
Cleared
Jun 20, 2011
BIODESIGN NIPPLE RECONSTRUCTION CYLINDER
FTM
Mesh, Surgical
129d
Cleared
Jun 16, 2011
ELTA WOUND CLEANSER
FRO
Dressing, Wound, Drug
177d
Cleared
Jun 16, 2011
GUARDACARE
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
185d
Cleared
Jun 09, 2011
ATRICURE DISSECTOR
FTD
Lamp, Surgical
58d
Cleared
Jun 08, 2011
ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO
GDW
Staple, Implantable
49d
Cleared
Jun 08, 2011
IMESH TACKER
GDW
Staple, Implantable
84d
Cleared
Jun 03, 2011
V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)...
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
10d
Cleared
Jun 03, 2011
EMULSION SB
FRO
Dressing, Wound, Drug
79d
Cleared
Jun 02, 2011
HET BIPOLAR ELECTROCAUTERY FORCEPS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
135d
Cleared
May 31, 2011
FORCETRIAD ELECTROSURGICAL GENERATOR
GEI
Electrosurgical, Cutting & Coagulation & Accessories
123d
Cleared
May 27, 2011
HAIRMAX LASERCOMB
OAP
Laser, Comb, Hair
121d
Cleared
May 27, 2011
PEAK SUCTION COAGULATOR
GEI
Electrosurgical, Cutting & Coagulation & Accessories
151d
Cleared
May 26, 2011
ATRICURE CRYO MODULE
GEH
Unit, Cryosurgical, Accessories
41d
Cleared
May 24, 2011
SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM
GDW
Staple, Implantable
29d
Cleared
May 19, 2011
SYNTHES HEMOSTATIC BONE PUTTY (HBP)
MTJ
Wax, Bone
140d
Cleared
May 19, 2011
UNIMAX SUCTION IRRIGATION SET
GCJ
Laparoscope, General & Plastic Surgery
171d
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