Cleared Traditional

K200641 - HaloGUARD Protective Disc with CHG

K200641 · Attwill Medical Solutions · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Sep 2020
Decision
176d
Days
-
Risk

K200641 is an FDA 510(k) clearance for the HaloGUARD Protective Disc with CHG. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Attwill Medical Solutions (Lodi, US). The FDA issued a Cleared decision on September 3, 2020 after a review of 176 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.

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Submission Details

510(k) Number K200641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2020
Decision Date September 03, 2020
Days to Decision 176 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
61d slower than avg
Panel avg: 115d · This submission: 176d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 222
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