Cleared Traditional

K880907 - TRIANGLE SPONGE

K880907 · Ormed Mfg., Inc. · General & Plastic Surgery device
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Mar 1988
Decision
14d
Days
-
Risk

K880907 is an FDA 510(k) clearance for the TRIANGLE SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Ormed Mfg., Inc. (Buffalo, US). The FDA issued a Cleared decision on March 17, 1988 after a review of 14 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 Ormed Mfg., Inc. devices

FDA 510(k) Submission Details - K880907

510(k) Number K880907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1988
Decision Date March 17, 1988
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 156
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K880907.
ROSEBUD DISSECTORS
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K880853 · Ormed Mfg., Inc. · Mar 1988
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K880854 · Ormed Mfg., Inc. · Mar 1988
TRACHEOTOMY SPONGES
K880909 · Ormed Mfg., Inc. · Mar 1988
ROUND STICK SPONGES
K880910 · Ormed Mfg., Inc. · Mar 1988
BLUNT SPONGE
K880911 · Ormed Mfg., Inc. · Mar 1988