Data / Medical devices / Poland / LiNA Medical Polska sp. z o.o

LiNA Medical Polska sp. z o.o: FDA-registered device maker in Tarnowo Podgorne Wielkopolskie, Poland, 1 510(k) clearance

Name: LiNA Medical Polska sp. z o.o FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

LiNA Medical Polska sp. z o.o is registered with the FDA (registration 3007699067) in Tarnowo Podgorne Wielkopolskie, Poland. It lists 16 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 22, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3007699067
Address: ul. Rolna 8A Sady, Tarnowo Podgorne Wielkopolskie, Poland, 62-080
Owner or operator: LINA MEDICAL APS (9044000)
Roles: Contract manufacturer, Manufacturer
First device listed: December 29, 2006
Registered through: 2026
Brand names listed: LiNA CystoVu HD (CYV-100-5; CYV-101-5), LiNA CystoVu HD Biopsy Forceps (CYV-FCP-5), LiNA CystoVu HD Grasper (CYV-GRA-5), LiNA ScopeVu (SCP-100-1), LiNA SeaStar, SS model (4000-S-SS), Skater Fix (8199)

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Contract manufacturer	accessdata.fda.gov
Biopsy Needle	FCG	2	Contract manufacturer	accessdata.fda.gov
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)	HIN	2	Contract manufacturer	accessdata.fda.gov
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	KNF	2	Contract manufacturer	accessdata.fda.gov
Cystoscope And Accessories, Flexible/Rigid	FAJ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer	accessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	PTS	2	Manufacturer	accessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2	Contract manufacturer	accessdata.fda.gov
Fluid Drainage Tray	PXU	1	Contract manufacturer	accessdata.fda.gov
Forceps	HTD	1	Contract manufacturer	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Manufacturer	accessdata.fda.gov
Hysteroscope (And Accessories)	HIH	2	Contract manufacturer	accessdata.fda.gov
Hysteroscope Accessories	NWW	1	Contract manufacturer	accessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)	HET	2	Contract manufacturer	accessdata.fda.gov
Retractor	GAD	1	Contract manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Contract 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
August 22, 2024	K240227	LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1)	FAJ	Substantially Equivalent	Lina Medical Aps	accessdata.fda.gov

Compare with other makers

Updated August 22, 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.