Cleared Traditional

K940345 - TRIANGULAR BANDAGE

K940345 · Certified Safety Mfg., Inc. · General & Plastic Surgery device
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Feb 1994
Decision
31d
Days
-
Risk

K940345 is an FDA 510(k) clearance for the TRIANGULAR BANDAGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Certified Safety Mfg., Inc. (Kansas City, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 31 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 Certified Safety Mfg., Inc. devices

FDA 510(k) Submission Details - K940345

510(k) Number K940345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1994
Decision Date February 25, 1994
Days to Decision 31 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
84d faster than avg
Panel avg: 115d · This submission: 31d
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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8 X 10 NON-STICK PAD
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TRAUMA PAD 5 X 9
K940348 · Certified Safety Mfg., Inc. · Feb 1994
EXTRA LARGE COMPRESS DRESSING
K940351 · Certified Safety Mfg., Inc. · Feb 1994
NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSING
K935930 · Mcneil Healthcare, Inc. · Feb 1994