Cleared Traditional

K872572 - PHARMANET (TM) (FDA 510(k) Clearance)

K872572 · Pharmacia, Inc. · General & Plastic Surgery device
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Jan 1988
Decision
199d
Days
-
Risk

K872572 is an FDA 510(k) clearance for the PHARMANET (TM). Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on January 14, 1988 after a review of 199 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 K872572 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 29, 1987
Decision Date January 14, 1988
Days to Decision 199 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
85d slower than avg
Panel avg: 114d · This submission: 199d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -