Identity
- Trade Name
- RenalCryo™ FDA UDI
- Generic Name
- Cryosurgical set FDA UDI
- Device Name
- Endocare™ 1.7 mm RenalCryo™ Long Shaft Cryoprobe FDA UDI
- Model / Reference
- RS-17L FDA UDI
- Description
- Endocare™ 1.7 mm RenalCryo™ Long Shaft Cryoprobe FDA UDI
Identifiers
- Catalog Number
- RS-17L FDA UDI
- Primary DI / UDI-DI
- 00810563020052 FDA UDI
- 510(k) Number
- K153489 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- Cryosurgical set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4350 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 1.7 Millimeter FDA UDI
Category: Cryosurgical set
RenalCryo™ by Endocare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cryosurgical set.
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Cleared under the same submission
K153489 also covers:
- Cryocare CS™ — ENDOCARE, INC.
- Cryocare CS™ — ENDOCARE, INC.
- Cryocare CS™ — ENDOCARE, INC.
- Cryocare CS™ — ENDOCARE, INC.
- Cryocare CS™ — ENDOCARE, INC.
- PerCryo™ — ENDOCARE, INC.
- PerCryo™ — ENDOCARE, INC.
- PerCryo™ — ENDOCARE, INC.
- PerCryo™ — ENDOCARE, INC.
- RenalCryo™ — ENDOCARE, INC.
- RenalCryo™ — ENDOCARE, INC.
- RenalCryo™ — ENDOCARE, 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
- Endocare, Inc.
Sources (1)
- FDA UDI a1193e58-4124-47cb-8f14-56a7a58a44f1 37 fields · synced May 30, 2026