Medical Device Manufacturer · US , Glen Allen , VA

Gallini U.S., LLC - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1997

Recent clearances: GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE, GALLINI ATRA-CUT NEEDLE, GALLINI BYCUT NEEDLE

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gallini U.S., LLC Gastroenterology & Urology ✕

10 devices

1-10 of 10

Cleared Aug 12, 1999

GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE

Gastroenterology & Urology · 17d

Cleared May 19, 1999

GALLINI ATRA-CUT NEEDLE

Gastroenterology & Urology · 82d

Cleared May 17, 1999

GALLINI BYCUT NEEDLE

Gastroenterology & Urology · 74d

Cleared Jul 08, 1998

SPEED-CUT AUTOMATIC BIOPSY SYSTEM

Gastroenterology & Urology · 90d

Cleared May 21, 1998

Gastroenterology & Urology · 90d

Cleared May 06, 1998

QUICK-CUT AUTOMATIC BIOPSY SYSTEM

Gastroenterology & Urology · 89d

Cleared Feb 18, 1998

Gastroenterology & Urology · 26d

Cleared Jan 30, 1998

Gastroenterology & Urology · 66d

Cleared Jan 09, 1998

GALLINI ABS DEVICE

Gastroenterology & Urology · 140d

Cleared Jul 29, 1997

GALLINI COAXIAL INTRODUCER

Gastroenterology & Urology · 42d