Bibag

Q: When was Bibag cleared by the FDA?

Bibag (K791198) received a 510(k) decision of Substantially Equivalent on July 30, 1979, 34 days after the submission was received.

Q: What is the product code of K791198?

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.

FDA 510(k) K791198 · Ab Medett Produkter

Substantially Equivalent

510(k) numberK791198

Submission

Device name: Bibag
Applicant: Ab Medett Produkter
Walker, MI, US
Received: June 26, 1979
Decision date: July 30, 1979
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

Other 510(k)s with product code KNX

510(k)	Device	Applicant	Decision
K110518	IbagKNX · Traditional	Future Path Medical, LLC	06/24/2011SE
K973364	4L Drainage Bag, 4L Bag for Peritoneal Dialysis, 4L Urinary Drainage BagKNX · Traditional	Maersk Medical A/S	03/17/1998SE
K972887	Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary Leg BagKNX · Traditional	Medline Industries, Inc.	12/11/1997SE
K971271	Besecure External Urinary Collection SystemKNX · Traditional	Urology Research Intl., Inc.	08/18/1997SE
K971929	Amsino Urinary Leg BagKNX · Traditional	Amsino Intl., Inc.	08/06/1997SE
K971764	Welcon Hue-Vu Urinary Drainage BagKNX · Traditional	Welcon, Inc.	07/29/1997SE
K964690	Liberty ValveKNX · Traditional	Cleveland Medical Devices, Inc.	03/21/1997SE
K964745	Amsino Urinary Drainage BagKNX · Traditional	Amsino Intl., Inc.	03/18/1997SE
K962652	Urinary Drainage Bag, (Reorder No. 0749 - Product No. 900-749)KNX · Traditional	Customed, Inc.	10/04/1996SE
K960949	Prosys Bedside Drainage Bag (Sterile) Model 650167KNX · Traditional	Bristol-Myers Squibb	04/19/1996SE

More from Bristol-Myers Squibb

510(k)	Device	Decision
K791197	Uridrop SpecialKNK · Traditional	07/30/1979SE
K791196	UridropKNX · Traditional	07/30/1979SE

Questions and answers

When was Bibag cleared by the FDA?

Bibag (K791198) received a 510(k) decision of Substantially Equivalent on July 30, 1979, 34 days after the submission was received.

What is the product code of K791198?

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.