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Silicone Supra-Pubic Catheter (Ordinary Balloon)

FDA UDIEUDAMED

Class II (US FDA UDI)

by Fortune Medical Instrument Corp.

Identity

Trade Name
Silicone Supra-Pubic Catheter (Ordinary Balloon) FDA UDI
Generic Name
Suprapubic drainage catheter FDA UDI
Model / Reference
1857-0212 FDA UDI

Identifiers

Primary DI / UDI-DI
04710961933472 FDA UDI
510(k) Number
K014002 FDA UDI
FDA Product Code
KOB FDA UDI
GMDN Term
Suprapubic drainage catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5090 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: Suprapubic drainage catheter

Silicone Supra-Pubic Catheter (Ordinary Balloon) by Fortune Medical Instrument Corp. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Suprapubic drainage catheter.

Cleared under the same submission

K014002 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fortune Medical Instrument Corp.

Sources (2)

  • FDA UDI f189c12b-53cd-4c13-8df9-5500f49fda88 33 fields · synced Jun 20, 2026
  • EUDAMED 1 fields · synced May 28, 2026