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
18256
Total
18211
Cleared
137d
Avg (2y)
1976
Since
7715 General & Plastic Surgery devices
Cleared
Dec 07, 1990
NIDEK INC. MODEL AC-2000 DERM
GEX
Powered Laser Surgical Instrument
73d
Cleared
Dec 04, 1990
FLEXISYS
GEX
Powered Laser Surgical Instrument
88d
Cleared
Nov 26, 1990
INTRASITE GEL (LABELING REVISION)
KMF
Bandage, Liquid
61d
Cleared
Nov 26, 1990
MENTOR TISSUE EXPANDERS W/TDMAC COATING
LCJ
Tissue Expander And Accessories
496d
Cleared
Nov 23, 1990
HTR POLYMER, HTR-MX
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
78d
Cleared
Nov 23, 1990
CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER
GEX
Powered Laser Surgical Instrument
128d
Cleared
Nov 21, 1990
ELASTOPLAST
KGX
Tape And Bandage, Adhesive
50d
Cleared
Nov 21, 1990
CODMAN COLLINS RADIOPARENT STERNAL BLADES
DWH
Blade, Saw, Surgical, Cardiovascular
58d
Cleared
Nov 21, 1990
ACCUPLACE (TM)
GDF
Guide, Needle, Surgical
71d
Cleared
Nov 21, 1990
MEDILAS 4060N FIBERTOM(R) SURGICAL LASER
GEX
Powered Laser Surgical Instrument
75d
Cleared
Nov 21, 1990
DERMASORB WOUND CONTACT LAYER DRESSING
KOZ
Beads, Hydrophilic, For Wound Exudate Absorption
99d
Cleared
Nov 14, 1990
NONABSORBABLE SILK SURGICAL SUTURE (SECOND SOURCE)
GAP
Suture, Nonabsorbable, Silk
15d
Cleared
Nov 14, 1990
NONABSORBABLE SILK SURGICAL SUTURE
GAP
Suture, Nonabsorbable, Silk
47d
Cleared
Oct 31, 1990
ELLA BREAST FORM
KCZ
Prosthesis, Breast, External, Used With Adhesive
56d
Cleared
Oct 31, 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E
GDM
Needle, Aspiration And Injection, Reusable
76d
Cleared
Oct 31, 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U
GDM
Needle, Aspiration And Injection, Reusable
76d
Cleared
Oct 31, 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V
GDM
Needle, Aspiration And Injection, Reusable
76d
Cleared
Oct 31, 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U
GDM
Needle, Aspiration And Injection, Reusable
76d
Cleared
Oct 30, 1990
MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP
GET
Motor, Surgical Instrument, Pneumatic Powered
28d
Cleared
Oct 26, 1990
SLT CONTACT LASER SYSTEM ND:YAG MEDICAL LASER SYST
GEX
Powered Laser Surgical Instrument
60d
Cleared
Oct 23, 1990
ALLEVYN DRESSING CLAIMS CHANGE
KOZ
Beads, Hydrophilic, For Wound Exudate Absorption
27d
Cleared
Oct 11, 1990
NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT
KCZ
Prosthesis, Breast, External, Used With Adhesive
20d
Cleared
Oct 11, 1990
MDLS 4000/4900/6000/8000/8900/LUXUS 60/100 ND:YAG
GEX
Powered Laser Surgical Instrument
76d
Cleared
Oct 11, 1990
SHARPLAN CO2 LASERS, MODEL NUMBERS 1050 AND 1075
GEX
Powered Laser Surgical Instrument
80d
Cleared
Oct 03, 1990
CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM
GEX
Powered Laser Surgical Instrument
92d
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