Safestretch Incontinence System

FDA 510(k) K851681 · Dbt Medical , Ltd.

Substantially Equivalent

510(k) numberK851681

Submission

Device name
Safestretch Incontinence System
Applicant
Dbt Medical , Ltd.
Witney,0x8 7az, GB
Received
April 23, 1985
Decision date
June 28, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KNX – Collector, Urine, (And Accessories) For Indwelling Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5250
Specialty
Gastroenterology, Urology

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More from Bristol-Myers Squibb

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K851680Ostomy Bags IleostomyEXB · Traditional 06/27/1985SE
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K851682Safeseal Reusable Urinal SystemEXJ · Traditional 06/24/1985SE

Questions and answers

When was Safestretch Incontinence System cleared by the FDA?

Safestretch Incontinence System (K851681) received a 510(k) decision of Substantially Equivalent on June 28, 1985, 66 days after the submission was received.

What is the product code of K851681?

The FDA product code is KNX – Collector, Urine, (And Accessories) For Indwelling Catheter, a Class II (moderate risk) device regulated under 21 CFR 876.5250.