MKY · Class I · 21 CFR 878.4320

FDA Product Code MKY: System, Skin Closure

Leading manufacturers include Progressive Surgical Products, Inc., Wisebands , Ltd. and Life Medical Sciences, Inc..

6
Total
6
Cleared
133d
Avg days
1994
Since

FDA 510(k) Cleared System, Skin Closure Devices (Product Code MKY)

6 devices
1–6 of 6
Cleared Mar 15, 2001
WISEBANDS SKIN CLOSURE DEVICE
K002315
Wisebands , Ltd.
General & Plastic Surgery · 227d
Cleared Sep 08, 1998
PROXIDERM, MODELS TN 460, TN 90 460, BK 460
K982439
Progressive Surgical Products, Inc.
General & Plastic Surgery · 56d
Cleared Apr 16, 1997
PROXIDERM (D-460,D 90 460,D 180,460, PS 460)
K970439
Progressive Surgical Products, Inc.
General & Plastic Surgery · 70d
Cleared Jan 14, 1997
PHOENIX ETE TISSUE EXTENSION SYSTEM
K962144
Phoenix Biomedical Corp.
General & Plastic Surgery · 225d
Cleared Nov 04, 1994
PROXIDERM (TENTATIVE)
K942425
Progressive Surgical Products, Inc.
General & Plastic Surgery · 168d
Cleared Jul 19, 1994
SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM
K942526
Life Medical Sciences, Inc.
General & Plastic Surgery · 53d

About Product Code MKY - Regulatory Context