Identity
- Trade Name
- Lumax™ TS Pro FDA UDI
- Generic Name
- Urodynamic measurement system FDA UDI
- Device Name
- Lumax™ TS Pro Fiberoptic Cystometry System FDA UDI
- Model / Reference
- TSBAS FDA UDI
- Description
- Lumax™ TS Pro Fiberoptic Cystometry System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937013360 FDA UDI
- 510(k) Number
- K953734 FDA UDI
- FDA Product Code
- FEN FDA UDI
- GMDN Term
- Urodynamic measurement system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urodynamic measurement system
Lumax™ TS Pro by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K953734 also covers:
- Hand Held Remote — CooperSurgical, Inc.
- Infusion Transducer — CooperSurgical, Inc.
- Lumax — CooperSurgical, Inc.
- Lumax — CooperSurgical, Inc.
- Lumax TS Pro — CooperSurgical, Inc.
- Lumax TS Pro — CooperSurgical, Inc.
- Lumax TS Pro — CooperSurgical, Inc.
- Lumax TS Pro — CooperSurgical, Inc.
- Lumax™ — CooperSurgical, Inc.
- Lumax™ TS Pro — CooperSurgical, Inc.
- Lumax™ TS Pro — CooperSurgical, Inc.
- Lumax™ TS Pro — CooperSurgical, 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 |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 3a943744-b58b-4fa8-8144-631436684dbc 34 fields · synced Jun 9, 2026