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
14095 General & Plastic Surgery devices
Cleared
May 12, 1997
SPECTRUM DESIGNS SPECTRAGEL
MDA
Elastomer, Silicone, For Scar Management
75d
Cleared
May 09, 1997
K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH
FPX
Strip, Adhesive, Closure, Skin
93d
Cleared
May 09, 1997
FOTONA SKINSCAN
GEX
Powered Laser Surgical Instrument
67d
Cleared
May 09, 1997
PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT
FTM
Mesh, Surgical
49d
Cleared
May 08, 1997
DUKAL NON ADHERENT DRESSING
EFQ
Gauze/sponge, Internal
91d
Cleared
May 08, 1997
DUKAL ABD COMBINE PAD
EFQ
Gauze/sponge, Internal
91d
Cleared
May 08, 1997
DERMAMEND FOAM ISLAND DRESSING
KMF
Bandage, Liquid
79d
Cleared
May 08, 1997
NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS
KDD
Kit, Surgical Instrument, Disposable
29d
Cleared
May 06, 1997
INSTRUMENT TRAY LINER
FSM
Tray, Surgical, Instrument
34d
Cleared
May 05, 1997
CENTAURI
GEX
Powered Laser Surgical Instrument
1432d
Cleared
May 05, 1997
CENTAURI
GEX
Powered Laser Surgical Instrument
1370d
Cleared
May 05, 1997
ANSPACH LUBRICATING SYSTEM II
GEY
Motor, Surgical Instrument, Ac-powered
82d
Cleared
May 05, 1997
MODIFIED USSC* POLYSORB SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
56d
Cleared
May 05, 1997
ELECTROSURGICAL ELECTRODE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
48d
Cleared
May 05, 1997
STANDARD & EXTENDED BLADE/NEEDLE/BALL
JOS
Electrode, Electrosurgical
34d
Cleared
May 02, 1997
BONE SOURCE HYDROXYAPATITE
LZK
Implant, Malar
88d
Cleared
Apr 30, 1997
TUNA 5 CATHETER
GEI
Electrosurgical, Cutting & Coagulation & Accessories
125d
Cleared
Apr 30, 1997
HYFRECATOR 2000
GEI
Electrosurgical, Cutting & Coagulation & Accessories
79d
Cleared
Apr 25, 1997
MODIFIED E-PACK PROCEDURE KIT
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
88d
Cleared
Apr 24, 1997
FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERS
GEX
Powered Laser Surgical Instrument
202d
Cleared
Apr 24, 1997
(FSI) LAPAROSCOPIC PROBE FOR ALL FSI ULE FF101 FIBERS. MODEL FSI FF101-LP-XXX, WHERE XXX = FIBER DIAMETERS 100, 200, 400
GEX
Powered Laser Surgical Instrument
202d
Cleared
Apr 23, 1997
KENDALL HYDROPHILIC POWDER WOUND DRESSING
KGN
Wound Dressing With Animal-derived Material(s)
90d
Cleared
Apr 23, 1997
SMITH & NEPHEW MIS INSTRUMENTS
GCJ
Laparoscope, General & Plastic Surgery
40d
Cleared
Apr 23, 1997
QA-ES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
28d
Cleared
Apr 22, 1997
RONIX II ROTARY ULTRASONIC SURGICAL SYSTEM
LFL
Instrument, Ultrasonic Surgical
147d
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