Identity
- Trade Name
- AMSure ® Hydrophilic Latex Foley Catheters FDA UDI
- Generic Name
- Ureteral catheter FDA UDI
- Device Name
- Hydrophilic Latex Foley Catheters, 26FR, 5cc. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Hydrophilic Latex Foley Catheters, 26FR, 5cc. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10704411009009 FDA UDI
- 510(k) Number
- K091699 FDA UDI
- FDA Product Code
- EZL FDA UDI
- GMDN Term
- Ureteral catheter 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
Yes
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
Category: Ureteral catheter
AMSure ® Hydrophilic Latex Foley Catheters by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ureteral catheter.
- Bard® Polyurethane Ureteral Catheters, Open Tip — C. R. Bard, Inc. · Class II
- Ureteral Catheter — Well Lead Medical Co., Ltd · Class II
- Bard® Woven Ureteral Catheter — C. R. Bard, Inc. · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Ureteral Catheter — Well Lead Medical Co., Ltd · Class II
- Coloplast — Coloplast A/S · Class II
- UroForce® Balloon Dilation Catheter — C. R. Bard, Inc. · Class II
- Metal Catheter — RZ-Medizintechnik GmbH · Class I
Cleared under the same submission
K091699 also covers:
- AMSure ® Hydrophilic Latex Foley Catheters — AMSINO INTERNATIONAL, INC.
- AMSure ® Hydrophilic Latex Foley Catheters — AMSINO INTERNATIONAL, INC.
- AMSure ® Hydrophilic Latex Foley Catheters — AMSINO INTERNATIONAL, INC.
- AMSure ® Hydrophilic Latex Foley Catheters — AMSINO INTERNATIONAL, INC.
- AMSure ® Hydrophilic Latex Foley Catheters — AMSINO INTERNATIONAL, INC.
- AMSure ® Hydrophilic Latex Foley Catheters — AMSINO INTERNATIONAL, INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (1)
- FDA UDI 36a243e0-873b-4e2c-8c1d-5b159186e6f7 34 fields · synced Jun 1, 2026