Zutron Colonoscope Stiffening Device
by Zutron Medical 510(k)
Active
510(k) K051068
Overview
The Zutron Colonoscope Stiffening Device is a colonoscope accessory designed to provide rigidity to flexible or rigid colonoscopes during gastrointestinal procedures. It is classified as a Class II medical device under regulation number 876.1500 and is intended for use in gastroenterology and urology specialties.
The device received traditional 510(k) clearance (K051068) from the FDA on July 11, 2005, and is substantially equivalent to a legally marketed predicate device. It is manufactured by Zutron Medical in Lenexa, Kansas, and is supplied as a non-sterile, reusable accessory for endoscopic use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051068 | Date11 Jul 2005 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FDF
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Zutron Medical, LLC
Questions
What is the Zutron Colonoscope Stiffening Device used for?
The Zutron Colonoscope Stiffening Device is a colonoscope accessory designed to provide rigidity to flexible or rigid colonoscopes during gastrointestinal procedures. It supports use in gastroenterology and urology specialties by enhancing device stability during endoscopic interventions.
Is the Zutron Colonoscope Stiffening Device sterile or non-sterile, and is it reusable?
The device is supplied as a non-sterile, reusable accessory for endoscopic use. It must be cleaned and reprocessed according to the manufacturer’s instructions before each reuse to ensure safe clinical application.
What regulatory pathway was used for the Zutron Colonoscope Stiffening Device, and when was it cleared?
The device received traditional 510(k) clearance (K051068) from the FDA on July 11, 2005, and is substantially equivalent to a legally marketed predicate device. This clearance pathway confirms its safety and effectiveness for the intended use.