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
13971 General & Plastic Surgery devices
Cleared
Dec 21, 2004
MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS
GEX
Powered Laser Surgical Instrument
148d
Cleared
Dec 21, 2004
NOVASYS TRANSURETHRAL RF SYSTEM
NVJ
Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
134d
Cleared
Dec 21, 2004
CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884
GEI
Electrosurgical, Cutting & Coagulation & Accessories
22d
Cleared
Dec 17, 2004
MD-6W WIRELESS CRITICAL DATA VIEWER
GCJ
Laparoscope, General & Plastic Surgery
56d
Cleared
Dec 17, 2004
NOUVAG AG - VACUSON 40 AND VACUSON 60
BTA
Pump, Portable, Aspiration (manual Or Powered)
53d
Cleared
Dec 17, 2004
CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES
GEX
Powered Laser Surgical Instrument
15d
Cleared
Dec 17, 2004
PERMACOL SURGICAL IMPLANT
FTL
Mesh, Surgical, Polymeric
9d
Cleared
Dec 16, 2004
OPUSDUO
GEX
Powered Laser Surgical Instrument
315d
Cleared
Dec 16, 2004
EMG MODEL SUA01 SUCTION UNIT
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
108d
Cleared
Dec 15, 2004
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000
NAY
System, Surgical, Computer Controlled Instrument
30d
Cleared
Dec 14, 2004
MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
GEX
Powered Laser Surgical Instrument
69d
Cleared
Dec 10, 2004
ARTHREX SUTURE GRAFTING KIT
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
184d
Cleared
Dec 10, 2004
UNICRYL M
NEW
Suture, Surgical, Absorbable, Polydioxanone
108d
Cleared
Dec 10, 2004
PANALIGHT-BLU, MODEL 4175
GEX
Powered Laser Surgical Instrument
24d
Cleared
Dec 10, 2004
BLUE ORTHOCORD SUTURE
NEW
Suture, Surgical, Absorbable, Polydioxanone
10d
Cleared
Dec 03, 2004
UNIMIDE
GAR
Suture, Nonabsorbable, Synthetic, Polyamide
101d
Cleared
Dec 03, 2004
CONTOUR FOREHEAD/BROWLIFT THREAD
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
60d
Cleared
Dec 01, 2004
MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450
FRO
Dressing, Wound, Drug
369d
Cleared
Dec 01, 2004
EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS
GEX
Powered Laser Surgical Instrument
133d
Cleared
Dec 01, 2004
UNISILK
GAP
Suture, Nonabsorbable, Silk
99d
Cleared
Dec 01, 2004
UNIPRO
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
99d
Cleared
Dec 01, 2004
UNIESTER C
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
99d
Cleared
Dec 01, 2004
OUTPATIENT III MINOR SURGERY LIGHT
FSY
Light, Surgical, Ceiling Mounted
90d
Cleared
Dec 01, 2004
HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P
LFL
Instrument, Ultrasonic Surgical
56d
Cleared
Dec 01, 2004
LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC)
FZP
Clip, Implantable
21d
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