Cleared Traditional

SPOON FORCEPS, 11MM (K911364) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911364 · Northgate Technologies, Inc. · Gastroenterology & Urology device
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Oct 1991
Decision
209d
Days
Class 2
Risk

K911364 is an FDA 510(k) clearance for the SPOON FORCEPS, 11MM. Classified as Lithotriptor, Biliary Mechanical (product code LQC), Class II - Special Controls.

Submitted by Northgate Technologies, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on October 23, 1991 after a review of 209 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4500 - 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 Northgate Technologies, Inc. devices

Submission Details

510(k) Number K911364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1991
Decision Date October 23, 1991
Days to Decision 209 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
79d slower than avg
Panel avg: 130d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LQC Lithotriptor, Biliary Mechanical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - LQC Lithotriptor, Biliary Mechanical

All 10
Devices cleared under the same product code (LQC) and FDA review panel - the closest regulatory comparables to K911364.
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A LITHOTRIPTER-COMPATIBLE BASKET
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LAPAROLITH
K905552 · Baxter Healthcare Corp · Dec 1991