Ostomy Bags Ileostomy

FDA 510(k) K851680 · Dbt Medical , Ltd.

Substantially Equivalent

510(k) numberK851680

Submission

Device name
Ostomy Bags Ileostomy
Applicant
Dbt Medical , Ltd.
Witney,0x8 7az, GB
Received
April 23, 1985
Decision date
June 27, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EXB – Collector, Ostomy
Device class
Class I (low risk)
Regulation
21 CFR 876.5900
Specialty
Gastroenterology, Urology

Other 510(k)s with product code EXB

510(k)DeviceApplicantDecision
K252140Heylo™ SystemEXB · Traditional Coloplast Corp.10/06/2025SE
K181643SmartBag (SmartPouch)EXB · Traditional 11 Health Technologies Limited11/16/2018SE
K140938Ostom-I AlertEXB · Traditional 11 Health and Technologies, LLC10/10/2014SE
K922730Lake Ostomy Care SetEXB · Traditional Lake Medical Products, Inc.12/30/1993SESK
K882878Odor-End Emergency Clean Up PowderEXB · Traditional Cdc Products Corp.12/08/1988SE
K881636Conseal Colostomy Continence System (One-Piece)EXB · Traditional Coloplast A/S07/13/1988SE
K880306Emergency-Clean Up(Tm) EcpEXB · Traditional Cdc Products Corp.05/20/1988SE
K872294Combination Nite Drainage UnitEXB · Traditional Arnold Technologies12/29/1987SE
K873929'Catch-It' or Fecal Containment DeviceEXB · Traditional Midwest Medical Co.12/03/1987SE
K871526Odor-Safe(Tm)(Liquid) Odor-Safe(Tm) PowderEXB · Traditional Cox Family Laboratories, Inc.10/13/1987SE

More from Cox Family Laboratories, Inc.

510(k)DeviceDecision
K851681Safestretch Incontinence SystemKNX · Traditional 06/28/1985SE
K851679Ostomy Bags ColostomyEXB · Traditional 06/27/1985SE
K851678Ostomy Bags UretherostomyEXB · Traditional 06/27/1985SE
K851682Safeseal Reusable Urinal SystemEXJ · Traditional 06/24/1985SE

Questions and answers

When was Ostomy Bags Ileostomy cleared by the FDA?

Ostomy Bags Ileostomy (K851680) received a 510(k) decision of Substantially Equivalent on June 27, 1985, 65 days after the submission was received.

What is the product code of K851680?

The FDA product code is EXB – Collector, Ostomy, a Class I (low risk) device regulated under 21 CFR 876.5900.