Cleared Traditional

K844596 - EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT (FDA 510(k) Clearance)

K844596 · Xanmed Corp. · General & Plastic Surgery device
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Aug 1985
Decision
248d
Days
-
Risk

K844596 is an FDA 510(k) clearance for the EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT.

Submitted by Xanmed Corp. (Washington, US). The FDA issued a Cleared decision on August 1, 1985 after a review of 248 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 K844596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received November 26, 1984
Decision Date August 01, 1985
Days to Decision 248 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
134d slower than avg
Panel avg: 114d · This submission: 248d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -