Mk-100100-10

by Microspecialities, Inc.

Mk-100100-10 is a Class I device made by Microspecialities, Inc., cleared under FDA 510(k) K020482 on 16 Dec 2002 and listed in FDA GUDID since 13 Feb 2019 (UDI-DI 10810003221053), 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	Number10810003221053 UDI-DI	Date13 Feb 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK020482	Date16 Dec 2002Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10810003221053
FDA 510(k) database 510(k) number K020482

Across registries

2 registries list this device

FDA 510(k) K020482 decided 16 Dec 2002 Active
FDA GUDID UDI-DI 10810003221053 listed 13 Feb 2019 Listed

Timeline

2 dated events

16 Dec 2002 Cleared FDA 510(k) K020482
13 Feb 2019 Listed FDA GUDID 10810003221053

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Keratome blade, single-use
Model / Ref / Catalog: MK-100100-10

Primary DI / UDI-DI: 10810003221053
510(k) Number: K020482
FDA product code: HNO
GMDN term: Keratome blade, single-use

Device class: Class I
Regulation number: 886.4370
GUDID distribution status: In Commercial Distribution

Size: Angle — -10 degree

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Properties

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

Other properties (9, all answered No)