Flex-Tech Balloon Dilator

FDA 510(k) K926038 · Cape Tech Medical Products

Substantially Equivalent

510(k) numberK926038

Submission

Device name
Flex-Tech Balloon Dilator
Applicant
Cape Tech Medical Products
Falmouth, MA, US
Received
December 1, 1992
Decision date
October 25, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KNQ – Dilator, Esophageal
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5365
Specialty
Gastroenterology, Urology

Other 510(k)s with product code KNQ

510(k)DeviceApplicantDecision
K122924Cre Fixed Wire Ballon Dilation CatheterKNQ · Special Boston Scientific Corp10/24/2012SE
K093236Ethicon Endo-Surgeryoptical DilatorKNQ · Special Ethicon Endo-Surgery, Inc.11/10/2009SE
K090183Hercules 3 Stage Wire Guided Dilation BalloonKNQ · Special Cook Endoscopy09/25/2009SE
K082995Smart DilatorKNQ · Traditional Safestitch Medical02/06/2009SE
K061937Cook Endoscopy Esophageal Dilation BalloonKNQ · Traditional Cook Endoscopy12/01/2006SE
K061787Maxforce TTS Single-Use Balloon DilatorKNQ · Traditional Boston Scientific Corp09/21/2006SE
K060302Inscope Precision Balloon Dilator - Wire GuidedKNQ · Traditional Cordis Europa, N.V.04/11/2006SE
K043605Inscope 3-STAGE Balloon DilatorKNQ · Traditional Cordis Europa, N.V.02/04/2005SE
K033936Bard Eliminator PET Balloon DilatorsKNQ · Special C.R. Bard, Inc.01/14/2004SE
K031147Optical DVS (Dual Vector Shearing) Esophageal DilatorKNQ · Traditional Ethicon Endo-Surgery, Inc.01/12/2004SE

More from Ethicon Endo-Surgery, Inc.

510(k)DeviceDecision
K926039Guide-Tech Encapsulated GuidewireKNY · Traditional 08/05/1993SE
K926040Heli-Tech Retrieval BasketLQR · Traditional 12/23/1992SE

Questions and answers

When was Flex-Tech Balloon Dilator cleared by the FDA?

Flex-Tech Balloon Dilator (K926038) received a 510(k) decision of Substantially Equivalent on October 25, 1993, 328 days after the submission was received.

What is the product code of K926038?

The FDA product code is KNQ – Dilator, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 876.5365.