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300135

by Microspecialities, Inc.

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

510(k) K980510

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10810003224771 UDI-DI Date29 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK980510 Date1 May 1998DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Keratome blade, single-use
Model / reference
300135
Primary DI / UDI-DI
10810003224771
510(k) Number
FDA product code
HNO
GMDN term
Keratome blade, single-use
Device class
Class I
Regulation number
886.4370
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K980510)

Other devices from Microspecialities, Inc.

  • MK8511CB

    Class I

  • MK8510LSK

    Class I

  • 300160

    Class I

  • 30020

    Class I

  • MK8507

    Class I

  • MK8508

    Class I

See all devices from Microspecialities, Inc. →

Properties

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

Other properties (9)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No