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FDA 510(k)

MYOCUR BLADE PAC

K-Number: K822392 · 1982-08-25

ApplicantMyocure, Inc.
Decision Date1982-08-25
Product CodeHMN
DecisionSubstantially Equivalent

Device Summary

MYOCUR BLADE PAC is the device name listed in this FDA 510(k) record. The listed applicant is Myocure, Inc.. It received FDA 510(k) clearance on 1982-08-25 under 510(k) number K822392. The device is classified under product code HMN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYOCUR BLADE PAC?

MYOCUR BLADE PAC is a medical device that received FDA 510(k) clearance on 1982-08-25. The listed applicant is Myocure, Inc.. The 510(k) number is K822392.

When did MYOCUR BLADE PAC receive FDA 510(k) clearance?

MYOCUR BLADE PAC received FDA 510(k) clearance on 1982-08-25, under 510(k) number K822392.

Who is the listed applicant for MYOCUR BLADE PAC?

The FDA 510(k) record lists Myocure, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYOCUR BLADE PAC?

The FDA product code for MYOCUR BLADE PAC is HMN.

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Other records listing Myocure, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K880345CYSTOTOMES/KNIFESK880346CANNULASK880347ANESTHESIA/RETROBULBAR NEEDLESK874057OPHTHALMIC TIP & BLADE SCALPELSK874056OPHTHALMIC DISPOSABLE BLADESK873385OPHTHALMIC PHACO-BLADE

View all 15 devices →

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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