Cleared Traditional

K971075 - PRIMED PRIME-PLUS COTTON GAUZE SPONGES

K971075 · Primeline Medical Products, Inc. · General & Plastic Surgery device
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Jun 1997
Decision
90d
Days
-
Risk

K971075 is an FDA 510(k) clearance for the PRIMED PRIME-PLUS COTTON GAUZE SPONGES. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Primeline Medical Products, Inc. (Alberta, CA). The FDA issued a Cleared decision on June 22, 1997 after a review of 90 days - within the typical 510(k) review window.

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.

View all Primeline Medical Products, Inc. devices

FDA 510(k) Submission Details - K971075

510(k) Number K971075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1997
Decision Date June 22, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

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