← Back to catalogue

Cystosure

FDA UDI

Class II (US FDA UDI)

by Emmy Medical

Identity

Trade Name
Cystosure FDA UDI
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
Device Name
Cystosure XL, 16 Fr, silicone catheter FDA UDI
Model / Reference
10-600 FDA UDI
Description
Cystosure XL, 16 Fr, silicone catheter FDA UDI

Identifiers

Primary DI / UDI-DI
00866403000203 FDA UDI
510(k) Number
K172422 FDA UDI
FDA Product Code
EZL FDA UDI
GMDN Term
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 16 French FDA UDI

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Cystosure by Emmy Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.

Cleared under the same submission

K172422 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Emmy Medical

Sources (1)

  • FDA UDI 2d8ff963-1d89-4532-ae08-ed73b9d977ba 36 fields · synced Jun 6, 2026