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
4110 General & Plastic Surgery devices
Cleared
May 04, 1989
AUTO SUTURE DISPOSABLE SURGICAL TROCAR*
FZT
Cutter, Surgical
76d
Cleared
Apr 28, 1989
AUTO SUTURE(R) ENDOSCOPIC GIA(TM) SURGICAL STAPLER
GDW
Staple, Implantable
24d
Cleared
Apr 27, 1989
TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X
NAD
Dressing, Wound, Occlusive
93d
Cleared
Apr 19, 1989
TITANIUM STAPLES
GDW
Staple, Implantable
57d
Cleared
Apr 07, 1989
MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP
GDO
Applier, Surgical, Clip
43d
Cleared
Mar 17, 1989
AUTO SUTURE ABSORBABLE FASCIA SURGICAL STAPLER*
GDW
Staple, Implantable
58d
Cleared
Mar 03, 1989
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
FRO
Dressing, Wound, Drug
88d
Cleared
Feb 10, 1989
SECOND ASSISTANT
FWZ
Operating Room Accessories Table Tray
9d
Cleared
Feb 10, 1989
ABSORBENT GAUZE ROLL
EFQ
Gauze/sponge, Internal
57d
Cleared
Feb 08, 1989
DERMASTRIP
KGX
Tape And Bandage, Adhesive
166d
Cleared
Feb 03, 1989
PRECISE ILA AND ILAN SURGICAL STAPLES
GDW
Staple, Implantable
45d
Cleared
Jan 24, 1989
GAUZE SWABS, NON-STERILE
EFQ
Gauze/sponge, Internal
40d
Cleared
Dec 27, 1988
PHARMASEAL STERILE WOUND CARE DRESSING
FRO
Dressing, Wound, Drug
69d
Cleared
Nov 17, 1988
BEAVER(R) HANDLE
GDZ
Handle, Scalpel
21d
Cleared
Aug 03, 1988
AUTO SUTURE DISP. ENDOSCOPIC SURG. CLIP APPLIER
FZP
Clip, Implantable
15d
Cleared
Jul 28, 1988
MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED
GAA
Needle, Aspiration And Injection, Disposable
9d
Cleared
Jun 27, 1988
3M WOUND CONTACT MATERIAL, PRODUCT #563X
NAD
Dressing, Wound, Occlusive
46d
Cleared
Jun 20, 1988
FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM
GEX
Powered Laser Surgical Instrument
165d
Cleared
Apr 14, 1988
THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM
FWF
Camera, Television, Endoscopic, Without Audio
35d
Cleared
Apr 01, 1988
TEGASORB ULCER DRESSING #90-XXX
FRO
Dressing, Wound, Drug
291d
Cleared
Mar 28, 1988
JOHNSON & JOHNSON FLUFF SPONGE
EFQ
Gauze/sponge, Internal
6d
Cleared
Mar 21, 1988
AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.
FRO
Dressing, Wound, Drug
10d
Cleared
Feb 24, 1988
HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS
GCY
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
7d
Cleared
Feb 03, 1988
ELECTRODE TIP CLEANER
GEI
Electrosurgical, Cutting & Coagulation & Accessories
77d
Cleared
Dec 17, 1987
AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE
GDH
Gouge, Surgical, General & Plastic Surgery
38d
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