Cleared Traditional

ELECTROCYN soma (K220286) - FDA 510(k) Clearance

K220286 · V3Bio Sdn. Bhd · General & Plastic Surgery device
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Dec 2022
Decision
323d
Days
-
Risk

K220286 is an FDA 510(k) clearance for the ELECTROCYN soma. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by V3Bio Sdn. Bhd (Simpang Ampat, MY). The FDA issued a Cleared decision on December 21, 2022 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance 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 V3Bio Sdn. Bhd devices

Submission Details

510(k) Number K220286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2022
Decision Date December 21, 2022
Days to Decision 323 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
208d slower than avg
Panel avg: 115d · This submission: 323d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Xfda
Miriam Walls

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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