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
13752 General & Plastic Surgery devices
Cleared
Jun 19, 2013
JOULE 810/940/980 MULTI-PLATFORM SYSTEM
GEX
Powered Laser Surgical Instrument
300d
Cleared
Jun 14, 2013
NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY
GEH
Unit, Cryosurgical, Accessories
65d
Cleared
Jun 14, 2013
FRAXEL DUAL 1550/1927 LASER SYSTEM
GEX
Powered Laser Surgical Instrument
140d
Cleared
Jun 14, 2013
LASER HELMET
OAP
Laser, Comb, Hair
262d
Cleared
Jun 13, 2013
SHASER V-MINI HAIR REMOVAL SYSTEM
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
161d
Cleared
Jun 12, 2013
MINT
NEW
Suture, Surgical, Absorbable, Polydioxanone
138d
Cleared
Jun 11, 2013
DISPOSABLE CIRCULAR STAPLER
GDW
Staple, Implantable
35d
Cleared
Jun 07, 2013
ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE
GCJ
Laparoscope, General & Plastic Surgery
49d
Cleared
Jun 07, 2013
DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK
NAY
System, Surgical, Computer Controlled Instrument
81d
Cleared
Jun 06, 2013
AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
FRO
Dressing, Wound, Drug
205d
Cleared
Jun 06, 2013
CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING
FRO
Dressing, Wound, Drug
216d
Cleared
Jun 05, 2013
WART FREEZE
GEH
Unit, Cryosurgical, Accessories
90d
Cleared
Jun 05, 2013
PHOTON PHOTON PLUS
GEX
Powered Laser Surgical Instrument
330d
Cleared
May 31, 2013
ENDOFORM RECONSTRUCTIVE TEMPLATE
FTM
Mesh, Surgical
88d
Cleared
May 31, 2013
SURGISEAL TOPICAL SKIN ADHESIVE
MPN
Tissue Adhesive For The Topical Approximation Of Skin
95d
Cleared
May 28, 2013
VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
GAR
Suture, Nonabsorbable, Synthetic, Polyamide
242d
Cleared
May 22, 2013
H-30 HOLMIUM LASER SYSTEM
GEX
Powered Laser Surgical Instrument
90d
Cleared
May 22, 2013
THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
175d
Cleared
May 22, 2013
BARLE TISSUE ADHESIVE
MPN
Tissue Adhesive For The Topical Approximation Of Skin
230d
Cleared
May 21, 2013
SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
257d
Cleared
May 20, 2013
AIGIS RX R PM/ AIGIS RX R ICD
FTL
Mesh, Surgical, Polymeric
46d
Cleared
May 17, 2013
ERCHONIA VERJU LASER SYSTEM WITH MASSAGER
OLI
Fat Reducing Low Level Laser
44d
Cleared
May 17, 2013
AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE
MPN
Tissue Adhesive For The Topical Approximation Of Skin
316d
Cleared
May 16, 2013
SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
16d
Cleared
May 15, 2013
GENESISPLUS
GEX
Powered Laser Surgical Instrument
272d
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