Cleared Traditional

K972781 - OT-1

K972781 is an FDA 510(k) clearance for OT-1, manufactured by Prism Therapeutics, LLC. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K972781 · Prism Therapeutics, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
56d
Days
Class 2
Risk

K972781 is an FDA 510(k) clearance for the OT-1. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Prism Therapeutics, LLC (Doswell, US). The FDA issued a Cleared decision on September 19, 1997 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Prism Therapeutics, LLC devices

FDA 510(k) Submission Details - K972781

510(k) Number K972781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1997
Decision Date September 19, 1997
Days to Decision 56 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 130d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FED Device Classification - Class 2, Special Controls

Product Code FED Endoscopic Access Overtube, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.
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 - FED Endoscopic Access Overtube, Gastroenterology-urology

All 67
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K972781.
URETERAL ACCESS SHEATH SET - NEW MODELS
K993650 · Applied Medical Resources · Dec 1999
URETERAL ACCESS SHEATH SET
K990775 · Applied Medical Resources · Apr 1999
BARD ENDOSCOPIC OVERTUBE (#000307)
K973500 · C.R. Bard, Inc. · Oct 1997
BARD ENDOSCOPIC OVERTUBE
K942044 · C.R. Bard, Inc. · Jun 1994
FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER
K921120 · Cook Urological, Inc. · Aug 1992
ST-E1 OVERTUBE
K903842 · Olympus Corp. · Jan 1991