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
14162 General & Plastic Surgery devices
Cleared
Jul 20, 1994
POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING
MGP
Dressing, Wound And Burn, Occlusive
37d
Cleared
Jul 19, 1994
DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH
GCJ
Laparoscope, General & Plastic Surgery
32d
Cleared
Jul 19, 1994
CLAMPS AND CLIPS
MDM
Instrument, Manual, Surgical, General Use
29d
Cleared
Jul 18, 1994
IMPLANTECH DORSAL NASAL IMPLANT
FZE
Prosthesis, Nose, Internal
31d
Cleared
Jul 13, 1994
CONMED SELECT-ONE LAPAROSCOPIC ELECTROSURGICAL BLADE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
23d
Cleared
Jul 12, 1994
VISITEC PRECISE-POINT
GAP
Suture, Nonabsorbable, Silk
64d
Cleared
Jul 11, 1994
E-Z DERM BIOSYNTHETIC WOUND DRESSING
KGN
Wound Dressing With Animal-derived Material(s)
258d
Cleared
Jul 08, 1994
COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODELS A & B
GEX
Powered Laser Surgical Instrument
354d
Cleared
Jul 08, 1994
PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT
FTL
Mesh, Surgical, Polymeric
37d
Cleared
Jul 08, 1994
LIFTING DISTENTION BALLOON SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
31d
Cleared
Jul 07, 1994
ORIGIN BALLOON RETRACTOR
GCJ
Laparoscope, General & Plastic Surgery
43d
Cleared
Jul 07, 1994
SURGIN IRRIGATION PUMP
GCJ
Laparoscope, General & Plastic Surgery
34d
Cleared
Jul 06, 1994
MEGABEAM DENTAL FIBER
GEX
Powered Laser Surgical Instrument
63d
Cleared
Jul 01, 1994
MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM
EPT
Microscope, Surgical
53d
Cleared
Jun 30, 1994
STRYKER ARTHROSCOPIC ACCESSORIES
GCJ
Laparoscope, General & Plastic Surgery
531d
Cleared
Jun 30, 1994
SHARPLAN SWIFTLASE 765/766/767 FLASHSCAN
GEX
Powered Laser Surgical Instrument
104d
Cleared
Jun 29, 1994
HYPERTONIC SALINE WET DRESSING - STERILE
KMF
Bandage, Liquid
65d
Cleared
Jun 29, 1994
INTRASITE
NAE
Dressing, Wound, Hydrogel Without Drug And/or Biologic
19d
Cleared
Jun 28, 1994
EYE TRAY
LRP
Tray, Surgical
160d
Cleared
Jun 28, 1994
R&D BATTERIES, PART NOS. 5243, 5104, AND 5481
BTA
Pump, Portable, Aspiration (manual Or Powered)
61d
Cleared
Jun 27, 1994
CURASALT HYPERTONIC SALINE DRESSING
KMF
Bandage, Liquid
34d
Cleared
Jun 22, 1994
SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
90d
Cleared
Jun 22, 1994
FEATHER-TOUCH SINGLE-STICK DEVICE
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
20d
Cleared
Jun 21, 1994
CHAKOFF ENDOSCOPY LAPAROSCOPIC INSTRUMENTATION
GEI
Electrosurgical, Cutting & Coagulation & Accessories
385d
Cleared
Jun 21, 1994
OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
372d
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