Data / Medical devices / Italy / Sterylab S.R.L.
Sterylab S.R.L.: FDA-registered device maker in Milan Milano, Italy, 1 510(k) clearance
Sterylab S.R.L. is registered with the FDA (registration 3007748770) in Milan Milano, Italy. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 27, 2005. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3007748770
- Address
- 20017 RHO Via Magenta, Milan Milano, Italy, 77/6
- Owner or operator
- Sterylab S.R.L. (10029426)
- Roles
- Manufacturer
- First device listed
- May 13, 2009
- Registered through
- 2026
- Brand names listed
- BEN-Bone Marrow needle, BSL-Best Lisa needles, CCH-Complete Chiba, CLT-Colt, ECX-Echochiba, FLP-Full Opty, FSC-Fast Cut, FSG-FASTGUN and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biopsy Needle | FCG | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 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 |
|---|---|---|---|---|---|---|
| July 27, 2005 | K051506 | MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY | FCG | Substantially Equivalent | Sterylab S.R.L. | accessdata.fda.gov |
Compare with other makers
Updated July 27, 2005. 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.