510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822392Substantially Equivalent

Myocur Blade Pac

Myocure, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822392 is the FDA 510(k) clearance record for MYOCUR BLADE PAC, a class III device, cleared for Myocure, Inc. on under FDA product code HMN (Suture, Nonabsorable, Ophthalmic). FDA records list 15 510(k) clearances for Myocure, Inc., from to . As of , FDA records show no recalls naming K822392.

Clearance record

Decision date
Received
(16 days to decision)
Product code
HMN Suture, Nonabsorable, Ophthalmic
Device class
Class III
Review panel
Unknown
Applicant
Myocure, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HMN

Trailing 12 months

FDA records hold no clearances under product code HMN in the trailing twelve months.

FDA records show no clearances under product code HMN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HMN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260