Cleared Traditional

K852202 - STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE

K852202 · Ormed Mfg., Inc. · General & Plastic Surgery device
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Jun 1985
Decision
36d
Days
-
Risk

K852202 is an FDA 510(k) clearance for the STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Ormed Mfg., Inc. (Buffalo, US). The FDA issued a Cleared decision on June 26, 1985 after a review of 36 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 - K852202

510(k) Number K852202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1985
Decision Date June 26, 1985
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
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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K852202 · STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE
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