Cleared Traditional

MEBO Wound Dressing (K193439) - FDA 510(k) Clearance

K193439 · Mebo Life Science, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Sep 2020
Decision
268d
Days
-
Risk

K193439 is an FDA 510(k) clearance for the MEBO Wound Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Mebo Life Science, Inc. (Brea, US). The FDA issued a Cleared decision on September 4, 2020 after a review of 268 days - an extended review 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: 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 Mebo Life Science, Inc. devices

Submission Details

510(k) Number K193439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2019
Decision Date September 04, 2020
Days to Decision 268 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 115d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Vee Care (Asia) Limited
Wei Shan Hsu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRO Dressing, Wound, Drug

All 168
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