Cleared Traditional

K971178 - RAND SURGICAL SPONGE

K971178 · Trans Aire · General & Plastic Surgery device
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Jun 1997
Decision
88d
Days
-
Risk

K971178 is an FDA 510(k) clearance for the RAND SURGICAL SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Trans Aire (Sacramento, US). The FDA issued a Cleared decision on June 27, 1997 after a review of 88 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 Trans Aire devices

FDA 510(k) Submission Details - K971178

510(k) Number K971178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1997
Decision Date June 27, 1997
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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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