Data / Medical devices / Italy / Assut Europe S.P.A.
Assut Europe S.P.A.: FDA-registered device maker in Magliano Dei Marsi L'Aquila, Italy, 3 510(k) clearances
Assut Europe S.P.A. is registered with the FDA (registration 9617547) in Magliano Dei Marsi L'Aquila, Italy. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 29, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9617547
- FEI number
- 3003272809
- Address
- Zona Industriale, Magliano Dei Marsi L'Aquila, Italy, AQ I-67062
- Owner or operator
- ASSUT EUROPE S.P.A. (9044488)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 23, 2016
- Registered through
- 2026
- Brand names listed
- ASSUFIL, Appolo Endosurgery 2-0 Polypropylene Suture (PLY-G02-020-APL), Assufil Monofilamento, Assut Fibloc Permanent Sutures, E-LOC Endo360 suture, E-LOC non absorbable Endo360, barbed suture, Filbloc, Filbloc Permanent and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Tissue Approximation Device | OCW | 2 | Contract manufacturer | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | 2 | Contract manufacturer, 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 29, 2017 | K171039 | Assut Filbloc Permanent Sutures | GAW | Substantially Equivalent | Assut Europe S.P.A. | accessdata.fda.gov |
| May 19, 2016 | K150553 | Filbloc | NEW | Substantially Equivalent | Assut Europe | accessdata.fda.gov |
| November 19, 2002 | K021767 | ASSUFIL | GAM | Substantially Equivalent | Assut Europe S.P.A. | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Surgical, Absorbable, Polydioxanone
- All makers of Endoscopic Tissue Approximation Device
- All makers of Suture, Nonabsorbable, Synthetic, Polypropylene
- All makers of Suture, Absorbable, Synthetic, Polyglycolic Acid
Updated August 29, 2017. 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.