Cleared Traditional

K823058 - DOSOMETRIC RELEASE STERILIZATION (FDA 510(k) Clearance)

K823058 · Stan-Pak Ent. · General & Plastic Surgery device
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Dec 1982
Decision
52d
Days
-
Risk

K823058 is an FDA 510(k) clearance for the DOSOMETRIC RELEASE STERILIZATION. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Stan-Pak Ent. (Mchenry, US). The FDA issued a Cleared decision on December 9, 1982 after a review of 52 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K823058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1982
Decision Date December 09, 1982
Days to Decision 52 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
62d faster than avg
Panel avg: 114d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -