Cleared Traditional

K974347 - BALDUR NON-STERILE COTTON SPONGES

K974347 · Baldur Systems Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 1998
Decision
83d
Days
-
Risk

K974347 is an FDA 510(k) clearance for the BALDUR NON-STERILE COTTON SPONGES. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Baldur Systems Corp. (Hayward, US). The FDA issued a Cleared decision on February 10, 1998 after a review of 83 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.

View all Baldur Systems Corp. devices

FDA 510(k) Submission Details - K974347

510(k) Number K974347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1997
Decision Date February 10, 1998
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
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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