Cleared Traditional

K940780 - SCOPEJOCKEY

K940780 is an FDA 510(k) clearance for SCOPEJOCKEY, manufactured by Fibertech Instruments, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCU cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K940780 · Fibertech Instruments, Inc. · Gastroenterology & Urology device
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May 1994
Decision
77d
Days
Class 2
Risk

K940780 is an FDA 510(k) clearance for the SCOPEJOCKEY. Classified as Endoscopic Storage Cover (product code OCU), Class II - Special Controls.

Submitted by Fibertech Instruments, Inc. (Baltimore, US). The FDA issued a Cleared decision on May 10, 1994 after a review of 77 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 Fibertech Instruments, Inc. devices

FDA 510(k) Submission Details - K940780

510(k) Number K940780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1994
Decision Date May 10, 1994
Days to Decision 77 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
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCU Device Classification - Class 2, Special Controls

Product Code OCU Endoscopic Storage Cover
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Protect Delicate Parts Of The Endoscope During Transport And Storage. May Also Be Used To Protect During Sterilization.
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.