Cleared Traditional

BALDUR NON-STERILE COTTON SPONGES (K974347) - FDA 510(k) Clearance

K974347 · Baldur Systems Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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

Submission Details

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
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K974347.
ABSORBENT GAUZE ROLL
K885143 · Smith & Nephew, Inc. · Feb 1989
GAUZE SWABS, NON-STERILE
K885142 · Smith & Nephew, Inc. · Jan 1989
JOHNSON & JOHNSON FLUFF SPONGE
K881222 · Johnson & Johnson Professionals, Inc. · Mar 1988
AQUATULLE FINE MESH NON-ADHERING DRESSING
K872759 · Smith & Nephew, Inc. · Sep 1987
NU-GAUZE SPONGE
K821150 · Johnson & Johnson Professionals, Inc. · Aug 1982