Sure-Flex Anastomotic Balloon Dilator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K901433

Identifiers

510(k) Number: K901433 FDA 510(k)
FDA Product Code: FGE FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 876.5010 FDA 510(k)
Regulation Number: 876.5010 FDA 510(k)
Advisory Committee: Gastroenterology, Urology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The SURE-FLEX ANASTOMOTIC BALLOON DILATOR is a innovative medical device designed for the minimally invasive treatment of gastroenterological and urological conditions. With its unique balloon technology, this device provides precise dilation and stenting capabilities, offering improved patient outcomes and reduced recovery time. As a highly regulated device, SURE-FLEX meets strict standards for safety and efficacy in the US market.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K901433	Class II	Active

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Manufacturer

Manufacturer: TeleMed Systems
FDA Applicant: Telemed Systems, Inc.

Sources (1)

FDA 510(k) K901433 24 fields · synced Jul 12, 2026