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
14005 General & Plastic Surgery devices
Cleared
Oct 18, 2002
PROFILE 1320 LASER SYSTEM
GEX
Powered Laser Surgical Instrument
88d
Cleared
Oct 17, 2002
DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
FRO
Dressing, Wound, Drug
421d
Cleared
Oct 17, 2002
BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
FTL
Mesh, Surgical, Polymeric
135d
Cleared
Oct 17, 2002
COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
GEI
Electrosurgical, Cutting & Coagulation & Accessories
15d
Cleared
Oct 16, 2002
NOVUS SPECTRA
GEX
Powered Laser Surgical Instrument
90d
Cleared
Oct 11, 2002
QUANTUM, MODELS SR, HR, DL
GEX
Powered Laser Surgical Instrument
210d
Cleared
Oct 11, 2002
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
GCJ
Laparoscope, General & Plastic Surgery
38d
Cleared
Oct 04, 2002
CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)
MGQ
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
346d
Cleared
Oct 04, 2002
CANDELA SMOOTHBEAM LASER SYSTEM
GEX
Powered Laser Surgical Instrument
291d
Cleared
Oct 03, 2002
AURORA SR
GEX
Powered Laser Surgical Instrument
83d
Cleared
Oct 03, 2002
MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
66d
Cleared
Oct 03, 2002
DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
20d
Cleared
Oct 01, 2002
NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES
GEX
Powered Laser Surgical Instrument
90d
Cleared
Sep 24, 2002
ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES
NAY
System, Surgical, Computer Controlled Instrument
167d
Cleared
Sep 23, 2002
RMNIPULSE HOLMIUM LASER SYSTEM/1210
GEX
Powered Laser Surgical Instrument
294d
Cleared
Sep 13, 2002
COATED VICRYL* (POLYGLACTIN 910) SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
60d
Cleared
Sep 10, 2002
AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM
LFL
Instrument, Ultrasonic Surgical
90d
Cleared
Sep 10, 2002
AVAGEN WOUND DRESSING
KGN
Wound Dressing With Animal-derived Material(s)
71d
Cleared
Sep 10, 2002
DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
FTL
Mesh, Surgical, Polymeric
19d
Cleared
Aug 28, 2002
PRECISION PLUS TUNA OFFICE SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
86d
Cleared
Aug 26, 2002
GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
88d
Cleared
Aug 23, 2002
ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE
LFL
Instrument, Ultrasonic Surgical
213d
Cleared
Aug 23, 2002
CHITO-SEAL
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
143d
Cleared
Aug 23, 2002
BCLEAR
FTC
Light, Ultraviolet, Dermatological
86d
Cleared
Aug 23, 2002
SURGISIS STAPLE LINE REINFORCEMENT
OXE
Mesh, Surgical, Collagen, Staple Line Reinforcement
60d
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