Medical Device Manufacturer · US , San Juan Capistrano , CA

Biopsys Medical, Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 1994

15

Total

15

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biopsys Medical, Inc. Gastroenterology & Urology ✕

8 devices

1-8 of 8

Cleared Mar 28, 1997

MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)

Gastroenterology & Urology · 43d

Cleared Sep 08, 1995

Gastroenterology & Urology · 21d

Cleared Apr 06, 1995

MODIFIED BIOPSY NEEDLE

Gastroenterology & Urology · 17d

Cleared Dec 09, 1994

BIOPSY DEVICE ACCESSORY

Gastroenterology & Urology · 25d

Cleared Dec 05, 1994

BIOPSY DEVICE ACCESSORY

Gastroenterology & Urology · 97d

Cleared Nov 09, 1994

MODIFIED BIOPSY NEEDLE

Gastroenterology & Urology · 20d

Cleared Jul 07, 1994

BIOPSY NEEDLE AND HOUSING

Gastroenterology & Urology · 34d

Cleared Apr 19, 1994

BIOPSY NEEDLE AND HOUSING

Gastroenterology & Urology · 20d