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
14018 General & Plastic Surgery devices
Cleared
Nov 24, 2000
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
LZK
Implant, Malar
70d
Cleared
Nov 24, 2000
IMAGE VASCULAR LASER
GEX
Powered Laser Surgical Instrument
56d
Cleared
Nov 22, 2000
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
FTL
Mesh, Surgical, Polymeric
86d
Cleared
Nov 21, 2000
ARAMIS DERMATOLOGICAL LASER
GEX
Powered Laser Surgical Instrument
89d
Cleared
Nov 13, 2000
SURGICAL SYSTEM WITH CRYOGUIDE
GEH
Unit, Cryosurgical, Accessories
83d
Cleared
Nov 08, 2000
STELLAR
FSY
Light, Surgical, Ceiling Mounted
90d
Cleared
Nov 03, 2000
CANDELA MID IR DIODE LASER SYSTEM
GEX
Powered Laser Surgical Instrument
87d
Cleared
Nov 03, 2000
3D ENDOSCOPE
GCJ
Laparoscope, General & Plastic Surgery
45d
Cleared
Nov 03, 2000
HERMES PORT EXPANDER
GCJ
Laparoscope, General & Plastic Surgery
21d
Cleared
Nov 03, 2000
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
GCI
Laryngoscope, Endoscope
18d
Cleared
Nov 02, 2000
OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A
GEX
Powered Laser Surgical Instrument
154d
Cleared
Oct 31, 2000
PLASMAKINETIC GENERATOR
GEI
Electrosurgical, Cutting & Coagulation & Accessories
29d
Cleared
Oct 31, 2000
SEEDNET, MODEL EP6T5, EP5E5
GEH
Unit, Cryosurgical, Accessories
29d
Cleared
Oct 23, 2000
MR-III
GAS
Suture, Nonabsorbable, Synthetic, Polyester
90d
Cleared
Oct 11, 2000
COMPOSIX E/X MESH
FTL
Mesh, Surgical, Polymeric
44d
Cleared
Oct 10, 2000
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4
LFL
Instrument, Ultrasonic Surgical
202d
Cleared
Oct 06, 2000
SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
50d
Cleared
Oct 06, 2000
TUTOPATCH
FTM
Mesh, Surgical
540d
Cleared
Oct 03, 2000
PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
120d
Cleared
Oct 02, 2000
GLUCANPRO CREAM
MGQ
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
84d
Cleared
Oct 02, 2000
BETA GLUCAN GEL (MACROPRO GEL)
MGQ
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
84d
Cleared
Oct 02, 2000
CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15
GEX
Powered Laser Surgical Instrument
66d
Cleared
Sep 26, 2000
OLYMPUS SONOSURG TROCAR XT3900 SYSTEM
LFL
Instrument, Ultrasonic Surgical
257d
Cleared
Sep 19, 2000
CANDELA SPTL-1B PULSED DYE LASER
GEX
Powered Laser Surgical Instrument
168d
Cleared
Aug 31, 2000
VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
23d
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