Mectron MF1

Mectron MF1 (03630001) 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 E322036300010), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberE322036300010 UDI-DI	Date5 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberK153743	Date25 May 2016Issued	StatusActive

Official records

FDA 510(k) database 510(k) number K153743

Across registries

2 registries list this device

FDA 510(k) K153743 decided 25 May 2016 Active
FDA GUDID UDI-DI E322036300010 listed 5 Sep 2016 Listed

Timeline

2 dated events

25 May 2016 Cleared FDA 510(k) K153743
5 Sep 2016 Listed FDA GUDID E322036300010

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Mectron
Generic name: Hard-tissue ultrasonic surgical system handpiece tip
Model / Ref / Catalog: MF1, 03630001

Primary DI / UDI-DI: E322036300010
510(k) Number: K153743
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

Other devices from Mectron SpA

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Mectron EX0410

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Mectron EX0510

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See all devices from Mectron SpA →

Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)