Cleared Traditional

K822392 - MYOCUR BLADE PAC (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K822392 · Myocure, Inc. · General & Plastic Surgery device
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Aug 1982
Decision
16d
Days
Class 3
Risk

K822392 is an FDA 510(k) clearance for the MYOCUR BLADE PAC. Classified as Suture, Nonabsorable, Ophthalmic (product code HMN), Class III - Premarket Approval.

Submitted by Myocure, Inc. (Walker, US). The FDA issued a Cleared decision on August 25, 1982 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Myocure, Inc. devices

Submission Details

510(k) Number K822392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1982
Decision Date August 25, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 114d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HMN Suture, Nonabsorable, Ophthalmic
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.