Cleared Traditional

K974493 - FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC EN...

K974493 is an FDA 510(k) clearance for FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC EN..., manufactured by Fiegert-Endotech Medizintechnik GmbH. The device is a Class 2 Gastroenterology & Urology device with product code FDS cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K974493 · Fiegert-Endotech Medizintechnik GmbH · Gastroenterology & Urology device
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Mar 1998
Decision
123d
Days
Class 2
Risk

K974493 is an FDA 510(k) clearance for the FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VI.... Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Fiegert-Endotech Medizintechnik GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on March 31, 1998 after a review of 123 days - within the typical 510(k) review window.

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: 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 Fiegert-Endotech Medizintechnik GmbH devices

FDA 510(k) Submission Details - K974493

510(k) Number K974493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1997
Decision Date March 31, 1998
Days to Decision 123 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
7d faster than avg
Panel avg: 130d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDS Device Classification - Class 2, Special Controls

Product Code FDS Gastroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Stomach. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FDS Gastroscope And Accessories, Flexible/rigid

All 65
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