Mectron MT1S-1O
by Mectron SpA
Mectron MT1S-1O (03600007) is a Class I device made by Mectron SpA, cleared under FDA 510(k) K153743 on 25 May 2016 and listed in FDA GUDID since 5 Sep 2016 (UDI-DI E322036000070), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberE322036000070 | Date5 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberK153743 | Date25 May 2016 | StatusActive |
Official records
- FDA 510(k) database K153743
Across registries
- FDA 510(k) K153743 decided 25 May 2016 Active
- FDA GUDID UDI-DI E322036000070 listed 5 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K153743
- Listed FDA GUDID E322036000070
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mectron
- Generic name
- Hard-tissue ultrasonic surgical system handpiece tip
- Model / Ref / Catalog
- MT1S-1O, 03600007
- Primary DI / UDI-DI
- E322036000070
- 510(k) Number
- FDA product code
- HWE, HBE, ERL, DZI, JDX
- GMDN term
- Hard-tissue ultrasonic surgical system handpiece tip
- Device class
- Class I
- Regulation number
- 878.4820, 882.4310, 874.4250, 872.4120, 888.4580
- GUDID distribution status
- In Commercial Distribution
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