Cleared Special

K011787 - PRECISION TUNA OFFICE SYSTEM WITH NO RE...

K011787 is an FDA 510(k) clearance for PRECISION TUNA OFFICE SYSTEM WITH NO RE..., manufactured by Vidamed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Special 510(k) pathway after a 28-day FDA review.

K011787 · Vidamed, Inc. · Gastroenterology & Urology device
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Jul 2001
Decision
28d
Days
Class 2
Risk

K011787 is an FDA 510(k) clearance for the PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Vidamed, Inc. (Fremont, US). The FDA issued a Cleared decision on July 6, 2001 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vidamed, Inc. devices

FDA 510(k) Submission Details - K011787

510(k) Number K011787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2001
Decision Date July 06, 2001
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

KNS Device Classification - Class 2, Special Controls

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 116
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K011787.
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