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H.S. Hospital Service S.P.A.: FDA-registered device maker in Rome Roma, Italy, 12 510(k) clearances

Name: H.S. Hospital Service S.P.A. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

H.S. Hospital Service S.P.A. is registered with the FDA (registration 8010312) in Rome Roma, Italy. It lists 6 device types. The FDA files 12 510(k) clearances under its listings, the newest dated October 9, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8010312
FEI number: 3008237808
Address: Via Zosimo 13 - 00178 Rome - Italy Via Angela Vacchi 23/25 - 04011 Aprilia (LT) - Italy, Rome Roma, Italy, 00178
Owner or operator: H.S. HOSPITAL SERVICE S.P.A. (8010312)
Roles: Manufacturer
First device listed: May 30, 2002
Registered through: 2026
Brand names listed: ALM SET, BIOMOL, BMN I TYPE, BMN J TYPE, ECOJEKT, HARVEST NEEDLE, HS AMICA, HS NOTA and more

Devices it lists

Device	Product code	Class	Role	Source
Biopsy Needle	FCG	2	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Manufacturer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Manufacturer	accessdata.fda.gov
Needle, Tumor Localization	MIJ	1	Manufacturer	accessdata.fda.gov
System, Ablation, Microwave And Accessories	NEY	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 9, 2024	K242029	TRAP EASY	KNW	Substantially Equivalent	H.S Hospital Service S.P.A	accessdata.fda.gov
February 9, 2024	K232072	AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G	GEI	Substantially Equivalent	H.S Hospital Service S.P.A	accessdata.fda.gov
October 28, 2019	K182605	HS AMICA devices family	GEI	Substantially Equivalent	H.S Hospital Service S.P.A	accessdata.fda.gov
September 10, 2015	K150112	HS AMICA DEVICES FAMILY	GEI	Substantially Equivalent	H.S Hospital Service S.P.A	accessdata.fda.gov
October 10, 2014	K131925	HS NOTA	FCG	Substantially Equivalent	H.S. Hospital Services S.P.A.	accessdata.fda.gov
September 29, 2009	K083157	HS AMICA	NEY	Substantially Equivalent	H.S Hospital Service S.P.A	accessdata.fda.gov
July 12, 2002	K021525	TOPCUT	FCG	Substantially Equivalent	H.S. Hospital Service S.R.L.	accessdata.fda.gov
June 25, 2002	K020987	BMN I TYPE MARROW ASPIRATION NEEDLE	KNW	Substantially Equivalent	H.S. Hospital Service S.R.L.	accessdata.fda.gov
February 5, 2002	K013692	TRAPSYSTEM SET	KNW	Substantially Equivalent	H.S. Hospital Service S.R.L.	accessdata.fda.gov
December 12, 2001	K013070	JAMSHIDI BIOPSY NEEDLE	FCG	Substantially Equivalent	H.S. Hospital Services S.P.A.	accessdata.fda.gov
December 19, 2000	K002947	BIOMOL ASPIRATION BIOPSY NEEDLE	FCG	Substantially Equivalent	H.S. Hospital Service S.R.L.	accessdata.fda.gov
December 19, 2000	K002944	PRECISA BIOPSY NEEDLE	FCG	Substantially Equivalent	H.S. Hospital Service S.R.L.	accessdata.fda.gov

Compare with other makers

Updated October 9, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.