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
18201
Total
18157
Cleared
138d
Avg (2y)
1976
Since
4109 General & Plastic Surgery devices
Cleared
Dec 20, 2000
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
JCT
Prosthesis, Tracheal, Expandable
78d
Cleared
Dec 08, 2000
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
GDW
Staple, Implantable
170d
Cleared
Dec 04, 2000
CLEARGLIDE PRECISION BIPOLAR DEVICE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
13d
Cleared
Nov 22, 2000
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
FTL
Mesh, Surgical, Polymeric
86d
Cleared
Nov 03, 2000
3D ENDOSCOPE
GCJ
Laparoscope, General & Plastic Surgery
45d
Cleared
Oct 23, 2000
MR-III
GAS
Suture, Nonabsorbable, Synthetic, Polyester
90d
Cleared
Oct 11, 2000
COMPOSIX E/X MESH
FTL
Mesh, Surgical, Polymeric
44d
Cleared
Jul 18, 2000
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
FZP
Clip, Implantable
71d
Cleared
Jul 10, 2000
PRONOVA NONABSORBABLE SUTURE, USP
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
54d
Cleared
Jun 01, 2000
KSEA MANHES PNEUMOTROCAR
GCJ
Laparoscope, General & Plastic Surgery
84d
Cleared
May 30, 2000
SOVEREIGN BIPOLAR INSTRUMENTS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
33d
Cleared
May 23, 2000
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
FTL
Mesh, Surgical, Polymeric
46d
Cleared
Apr 17, 2000
MEDLINE TENDER WET WOUND DRESSING
MGQ
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
329d
Cleared
Mar 30, 2000
MONOFILAMENT BIOSYN SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
84d
Cleared
Mar 24, 2000
AESCULAP BONE WAX
MTJ
Wax, Bone
80d
Cleared
Mar 13, 2000
DYONICS ELECTROBLADE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
77d
Cleared
Dec 06, 1999
SYNTHES LIGHT GUIDE
FQP
Lamp, Operating-room
63d
Cleared
Nov 18, 1999
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
JCT
Prosthesis, Tracheal, Expandable
114d
Cleared
Oct 05, 1999
DEXIDE BIPOLAR FORCEPS II** DEVICE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
22d
Cleared
Oct 05, 1999
DYONICS VARICOSE VEIN ABLATION BLADE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
214d
Cleared
Jul 30, 1999
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
MDA
Elastomer, Silicone, For Scar Management
49d
Cleared
Jul 20, 1999
CICACARE MANAGEMENT FOR SCARS
MDA
Elastomer, Silicone, For Scar Management
40d
Cleared
Jun 23, 1999
DEXIDE BIPOLAR FORCEPS II ** DEVICE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
22d
Cleared
Apr 30, 1999
ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC
GAL
Suture, Absorbable, Natural
18d
Cleared
Apr 14, 1999
SMITH & NEPHEW HANDPORT SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
63d
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