Cleared Traditional

K882529 - BUTCHER STRUNG TONSIL SPONGE

K882529 · Ormed Mfg., Inc. · General & Plastic Surgery device
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Jul 1988
Decision
27d
Days
-
Risk

K882529 is an FDA 510(k) clearance for the BUTCHER STRUNG TONSIL SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Ormed Mfg., Inc. (Buffalo, US). The FDA issued a Cleared decision on July 18, 1988 after a review of 27 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.

FDA 510(k) Submission Details - K882529

510(k) Number K882529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1988
Decision Date July 18, 1988
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
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 270
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K882529.
STICK SPONGE
K882712 · Bioseal · Aug 1988
GAUZE SPONGE
K882527 · Ormed Mfg., Inc. · Jul 1988
CYLINDRICAL SPONGE
K882528 · Ormed Mfg., Inc. · Jul 1988
TAPE STRUNG TONSIL SPONGE
K882530 · Ormed Mfg., Inc. · Jul 1988
GAUZE AND LAP SPONGES -STERILE & NON-STERILE
K881395 · A Plus International, Inc. · Apr 1988
INVESTIGATION KIT, SEXUAL ASSAULT DETERMINATION
K880208 · Dresser Argus, Inc. · Apr 1988
K882529 · BUTCHER STRUNG TONSIL SPONGE
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