Cleared Traditional

MITRASHEER TRANSPLANT DRESSING (K911649) - FDA 510(k) Clearance

K911649 · Polymint Industrial Co. , Ltd. · General & Plastic Surgery device
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Aug 1991
Decision
117d
Days
-
Risk

K911649 is an FDA 510(k) clearance for the MITRASHEER TRANSPLANT DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Polymint Industrial Co. , Ltd. (Wheat Ridge, US). The FDA issued a Cleared decision on August 7, 1991 after a review of 117 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Polymint Industrial Co. , Ltd. devices

Submission Details

510(k) Number K911649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1991
Decision Date August 07, 1991
Days to Decision 117 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
2d slower than avg
Panel avg: 115d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -