Cleared Traditional

K152533 - Xonrid Gel

K152533 · Helsinn Healthcare SA · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
421d
Days
-
Risk

K152533 is an FDA 510(k) clearance for the Xonrid Gel. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Helsinn Healthcare SA (Lugano, CH). The FDA issued a Cleared decision on October 28, 2016 after a review of 421 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Helsinn Healthcare SA devices

FDA 510(k) Submission Details - K152533

510(k) Number K152533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2015
Decision Date October 28, 2016
Days to Decision 421 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
306d slower than avg
Panel avg: 115d · This submission: 421d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Buchanan Ingersoll & Rooney PC
Barbara A Binzak Blumenfeld

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 607
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