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
14018 General & Plastic Surgery devices
Cleared
Jun 23, 2000
POLYESTER NONABSORBABLE SURGICAL SUTURES URP
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
73d
Cleared
Jun 23, 2000
NYLON, NONABSORBABLE SURGICAL SUTURES USP
GAR
Suture, Nonabsorbable, Synthetic, Polyamide
73d
Cleared
Jun 23, 2000
SILK, NONABSORBABLE, SURGICAL SUTURES, USP
GAP
Suture, Nonabsorbable, Silk
73d
Cleared
Jun 23, 2000
POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
73d
Cleared
Jun 23, 2000
PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP
GAL
Suture, Absorbable, Natural
60d
Cleared
Jun 07, 2000
HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL
GEI
Electrosurgical, Cutting & Coagulation & Accessories
58d
Cleared
Jun 07, 2000
ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL),
GEI
Electrosurgical, Cutting & Coagulation & Accessories
58d
Cleared
Jun 07, 2000
ACTICOAT PRIMARY ANTIMICROBIAL DRESSING
FRO
Dressing, Wound, Drug
342d
Cleared
Jun 05, 2000
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
JCT
Prosthesis, Tracheal, Expandable
154d
Cleared
Jun 05, 2000
CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX
GCJ
Laparoscope, General & Plastic Surgery
13d
Cleared
Jun 01, 2000
KSEA MANHES PNEUMOTROCAR
GCJ
Laparoscope, General & Plastic Surgery
84d
Cleared
Jun 01, 2000
LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)
GEX
Powered Laser Surgical Instrument
178d
Cleared
May 30, 2000
SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
88d
Cleared
May 30, 2000
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C
GEI
Electrosurgical, Cutting & Coagulation & Accessories
36d
Cleared
May 30, 2000
SOVEREIGN BIPOLAR INSTRUMENTS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
33d
Cleared
May 30, 2000
HM-930 ELECTROSURGICAL UNIT
GEI
Electrosurgical, Cutting & Coagulation & Accessories
188d
Cleared
May 26, 2000
CANDELA GENTLELASE GL DERMATOLOGICAL LASER
GEX
Powered Laser Surgical Instrument
161d
Cleared
May 23, 2000
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
FTL
Mesh, Surgical, Polymeric
46d
Cleared
May 18, 2000
PALOMAR SLP 2000
GEX
Powered Laser Surgical Instrument
155d
Cleared
May 16, 2000
SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR
GEI
Electrosurgical, Cutting & Coagulation & Accessories
8d
Cleared
May 15, 2000
STRYKER IRRIGATION TUBE SET
GCJ
Laparoscope, General & Plastic Surgery
90d
Cleared
May 11, 2000
UNI-LASER 430
GEX
Powered Laser Surgical Instrument
183d
Cleared
May 04, 2000
KAVO K.E.Y. LASER 1242
GEX
Powered Laser Surgical Instrument
52d
Cleared
May 03, 2000
ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01
GEI
Electrosurgical, Cutting & Coagulation & Accessories
54d
Cleared
May 02, 2000
SENTRY EXPANDING INTRODUCER SHEATH (EIS)
GCJ
Laparoscope, General & Plastic Surgery
74d
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