Cleared Traditional

MARLOW ANAL SPECULUM (K891352) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K891352 · Simpson/Basye, Inc. · Gastroenterology & Urology device
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Jun 1989
Decision
105d
Days
Class 1
Risk

K891352 is an FDA 510(k) clearance for the MARLOW ANAL SPECULUM. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by Simpson/Basye, Inc. (Wilmington, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - the FDA gastroenterology and urology device framework. 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Simpson/Basye, Inc. devices

Submission Details

510(k) Number K891352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1989
Decision Date June 23, 1989
Days to Decision 105 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 130d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOA Surgical Instruments, G-u, Manual (and Accessories)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.