Cleared Traditional

K760522 - TABLE, UROSURGICAL (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K760522 · Mallinckrodt Group, Inc. · Gastroenterology & Urology device
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Dec 1976
Decision
112d
Days
Class 1
Risk

K760522 is an FDA 510(k) clearance for the TABLE, UROSURGICAL. Classified as Table, Cystometric, Non-electric And Accessories (product code KQS), Class I - General Controls.

Submitted by Mallinckrodt Group, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1976 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4890 - 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 Mallinckrodt Group, Inc. devices

Submission Details

510(k) Number K760522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1976
Decision Date December 16, 1976
Days to Decision 112 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
18d faster than avg
Panel avg: 130d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQS Table, Cystometric, Non-electric And Accessories
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4890
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.