Medical Device Manufacturer · US , Fountain Valley , CA

Sutura, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2000

Recent clearances: SUPERSTITCH 5F, 12F, AND EL, SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW, SUPERSTITCH

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sutura, Inc. General & Plastic Surgery ✕

4 devices

1-4 of 4

Cleared Oct 19, 2006

SUPERSTITCH 5F, 12F, AND EL

General & Plastic Surgery · 86d

Cleared Dec 27, 2005

SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW

General & Plastic Surgery · 13d

Cleared Apr 17, 2002

SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X

General & Plastic Surgery · 26d

Cleared Sep 25, 2001

SUPERSTITCH VASCULAR SUTURING DEVICE

General & Plastic Surgery · 29d