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
14011 General & Plastic Surgery devices
Cleared
Jan 04, 2001
ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045
GEI
Electrosurgical, Cutting & Coagulation & Accessories
58d
Cleared
Dec 27, 2000
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
FTM
Mesh, Surgical
203d
Cleared
Dec 22, 2000
AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250
GEI
Electrosurgical, Cutting & Coagulation & Accessories
178d
Cleared
Dec 22, 2000
DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005
GCJ
Laparoscope, General & Plastic Surgery
14d
Cleared
Dec 20, 2000
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210
GEX
Powered Laser Surgical Instrument
145d
Cleared
Dec 20, 2000
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
JCT
Prosthesis, Tracheal, Expandable
78d
Cleared
Dec 20, 2000
REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY POWER CORD, MODEL V5100-00,V5701-00,V5702
GEI
Electrosurgical, Cutting & Coagulation & Accessories
26d
Cleared
Dec 15, 2000
ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07
LFL
Instrument, Ultrasonic Surgical
88d
Cleared
Dec 15, 2000
SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
GAN
Suture, Absorbable, Synthetic
79d
Cleared
Dec 15, 2000
LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)
GEX
Powered Laser Surgical Instrument
66d
Cleared
Dec 08, 2000
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
GDW
Staple, Implantable
170d
Cleared
Dec 08, 2000
THERMAGE THERMACOOL II SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
58d
Cleared
Dec 08, 2000
NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, NEEDLE TIP, BALL TIP
GEI
Electrosurgical, Cutting & Coagulation & Accessories
9d
Cleared
Dec 04, 2000
SCITON IMAGE HAIR REMOVAL LASER
GEX
Powered Laser Surgical Instrument
82d
Cleared
Dec 04, 2000
PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES
GEX
Powered Laser Surgical Instrument
80d
Cleared
Dec 04, 2000
REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
70d
Cleared
Dec 04, 2000
CLEARGLIDE PRECISION BIPOLAR DEVICE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
13d
Cleared
Nov 29, 2000
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
FTL
Mesh, Surgical, Polymeric
90d
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
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