Disposable Sure-Flex Balloon Dilatation Catheter

FDA UDI

Class II (US FDA UDI)

by TeleMed Systems

Identity

Trade Name: Disposable Sure-Flex Balloon Dilatation Catheter FDA UDI
Generic Name: Endoscopic gastrointestinal stenosis dilator FDA UDI
Device Name: Esophageal Dilator 8mm Diameter x 8cm Length Balloon Dimensions 200cm Total Catheter Length FDA UDI
Model / Reference: 1001 FDA UDI
Description: Esophageal Dilator 8mm Diameter x 8cm Length Balloon Dimensions 200cm Total Catheter Length FDA UDI

Identifiers

Primary DI / UDI-DI: 00813353010004 FDA UDI
510(k) Number: K901424 FDA UDI
FDA Product Code: KNQ FDA UDI
GMDN Term: Endoscopic gastrointestinal stenosis dilator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5365 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscopic gastrointestinal stenosis dilator

Disposable Sure-Flex Balloon Dilatation Catheter by TeleMed Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic gastrointestinal stenosis dilator.

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OnScope(TM) Endoscopic Dilator Kit — Micro-Tech (Nanjing) Co., Ltd. · Class II
BougieCap — Ovesco Endoscopy AG · Class II
BougieCap — Ovesco Endoscopy AG · Class II
BougieCap — Ovesco Endoscopy AG · Class II

Cleared under the same submission

K901424 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: TeleMed Systems

Sources (1)

FDA UDI 786df94a-6ba3-43f4-bbdf-2ca0946b2dbf 34 fields · synced May 30, 2026