Cleared Traditional

K941099 - CLEAN-SORB

K941099 · Hospital Specialty Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
207d
Days
-
Risk

K941099 is an FDA 510(k) clearance for the CLEAN-SORB. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Hospital Specialty Co. (Cleveland, US). The FDA issued a Cleared decision on September 30, 1994 after a review of 207 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Hospital Specialty Co. devices

FDA 510(k) Submission Details - K941099

510(k) Number K941099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1994
Decision Date September 30, 1994
Days to Decision 207 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 115d · This submission: 207d
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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