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
13837 General & Plastic Surgery devices
Cleared
Nov 05, 2009
LH-75 PHOTOTHERAPY SYSTEM
FTC
Light, Ultraviolet, Dermatological
156d
Cleared
Nov 03, 2009
EPICARE-DUO LASER SYSTEM
GEX
Powered Laser Surgical Instrument
153d
Cleared
Oct 30, 2009
ECO2 LASER SYSTEM
GEX
Powered Laser Surgical Instrument
196d
Cleared
Oct 30, 2009
SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS
FRO
Dressing, Wound, Drug
372d
Cleared
Oct 29, 2009
ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508
GEI
Electrosurgical, Cutting & Coagulation & Accessories
181d
Cleared
Oct 29, 2009
EXELO2, MODEL 4010
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
233d
Cleared
Oct 28, 2009
ACELL MATRISTEM WOUND SHEET
KGN
Wound Dressing With Animal-derived Material(s)
35d
Cleared
Oct 28, 2009
GIVEN ELECTROSURGICAL NEEDLE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
415d
Cleared
Oct 27, 2009
MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
165d
Cleared
Oct 22, 2009
MEDEOR MATRIX, MODELS 30010-XX (HYDRATED)
FTM
Mesh, Surgical
154d
Cleared
Oct 22, 2009
THERAFORM BILAYER
KGN
Wound Dressing With Animal-derived Material(s)
210d
Cleared
Oct 21, 2009
ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING
FRO
Dressing, Wound, Drug
166d
Cleared
Oct 14, 2009
FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
154d
Cleared
Oct 09, 2009
SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
129d
Cleared
Oct 09, 2009
LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L
GEI
Electrosurgical, Cutting & Coagulation & Accessories
147d
Cleared
Oct 07, 2009
OR-LIGHT
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
202d
Cleared
Oct 02, 2009
CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23
GEH
Unit, Cryosurgical, Accessories
113d
Cleared
Oct 01, 2009
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
NUV
Massager, Vacuum, Light Induced Heating
72d
Cleared
Oct 01, 2009
WATERLASE MD
GEX
Powered Laser Surgical Instrument
274d
Cleared
Sep 29, 2009
HS AMICA
NEY
System, Ablation, Microwave And Accessories
340d
Cleared
Sep 28, 2009
SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015
GCJ
Laparoscope, General & Plastic Surgery
110d
Cleared
Sep 28, 2009
ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)
FSS
Light, Surgical, Floor Standing
154d
Cleared
Sep 28, 2009
SPINEWAND SURGICAL DEVICE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
154d
Cleared
Sep 23, 2009
ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB
GCJ
Laparoscope, General & Plastic Surgery
85d
Cleared
Sep 23, 2009
LIPOEZE LASER ASSISTED ASPIRATION CANNULA
GEX
Powered Laser Surgical Instrument
98d
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