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Silicone 2-way Foley Balloon Catheter (Grooved Balloon)

FDA UDIEUDAMED

Class II (US FDA UDI)

by Fortune Medical Instrument Corp.

Identity

Trade Name
Silicone 2-way Foley Balloon Catheter (Grooved Balloon) FDA UDI
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
Model / Reference
1827-0024 FDA UDI

Identifiers

Primary DI / UDI-DI
04711182628536 FDA UDI
510(k) Number
K980919 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

No

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

Yes

FDA UDI

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Silicone 2-way Foley Balloon Catheter (Grooved Balloon) by Fortune Medical Instrument Corp. — Class II — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

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

Cleared under the same submission

K980919 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fortune Medical Instrument Corp.

Sources (2)

  • FDA UDI 76a8c137-3515-4a16-b777-ed21270e2f6a 33 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026