510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K002944Substantially Equivalent

Precisa Biopsy Needle

H.S. Hospital Service S.p.A., South Glastonbury CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002944 is the FDA 510(k) clearance record for PRECISA BIOPSY NEEDLE, a class II device, cleared for H.S. Hospital Service S.R.L. on under FDA product code FCG (Biopsy Needle). FDA records list 12 510(k) clearances for H.S. Hospital Service S.R.L., from to . As of , FDA records show no recalls naming K002944.

Clearance record

Decision date
Received
(89 days to decision)
Product code
FCG Biopsy Needle
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
H.S. Hospital Service S.R.L. 131 Hwy. Dr., South Glastonbury CT
510(k) summary
Summary
Third party review
No

Clearances, product code FCG

Trailing 12 months

FDA records hold no clearances under product code FCG in the trailing twelve months.

FDA records show no clearances under product code FCG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260