Cleared Traditional

K963064 - ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM

K963064 is an FDA 510(k) clearance for ANO-RECTAL MANOMETRY OPTION, manufactured by Laborie Medical Tech Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K963064 · Laborie Medical Tech Corp. · Gastroenterology & Urology device
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Jun 1997
Decision
302d
Days
Class 2
Risk

K963064 is an FDA 510(k) clearance for the ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Laborie Medical Tech Corp. (Williston, US). The FDA issued a Cleared decision on June 5, 1997 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - 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. Elevated predicate reliance profile. 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 Laborie Medical Tech Corp. devices

FDA 510(k) Submission Details - K963064

510(k) Number K963064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1996
Decision Date June 05, 1997
Days to Decision 302 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 131d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFX Device Classification - Class 2, Special Controls

Product Code FFX System, Gastrointestinal Motility (electrical)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1725
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 - FFX System, Gastrointestinal Motility (electrical)

All 52
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K963064.
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MICROINFUSOR
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DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION
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