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Myocur Blade Pac

by Myocure, Inc.

510(k) K822392

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK822392 Date25 Aug 1982ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HMN
Device Class
Class III
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Myocur Blade Pac is a Suture, Nonabsorable, Ophthalmic, designed for precise tissue approximation in ocular procedures. This device features a specialized blade mechanism intended for controlled suture placement, ensuring stability and accuracy in delicate surgical applications.

Supplied as a single-use, sterile instrument, the Myocur Blade Pac is intended for use in ophthalmic surgeries under aseptic conditions. It is classified as a Class III device under FDA regulations and holds a 510(k) clearance (K822392) with a product code of HMN. Storage should adhere to manufacturer guidelines to maintain sterility and functionality.

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