Identity
- Trade Name
- Amplatz FDA UDI
- Generic Name
- Endoscopic-access dilator, single-use FDA UDI
- Device Name
- Amplatz Renal Introducer FDA UDI
- Model / Reference
- G57465 FDA UDI
- Description
- Amplatz Renal Introducer FDA UDI
Identifiers
- Catalog Number
- ARI-300016-01 FDA UDI
- Primary DI / UDI-DI
- 00827002574656 FDA UDI
- 510(k) Number
- K172527 FDA UDI
- FDA Product Code
- LJE FDA UDI
- GMDN Term
- Endoscopic-access dilator, single-use FDA UDI
Classification
- Device Class
- U 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
Category: Endoscopic-access dilator, single-use
Amplatz by Cook Incorporated — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic-access dilator, single-use.
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation · Class II
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation · Class II
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation · Class II
- Porges Coloplast — Coloplast A/S · Class II
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation · Class II
- CONMED CleanGuide — Jiangsu Grit Medical Technology Co., Ltd. · Class II
- Navigator HD — Boston Scientific · Class II
- SEPLOU — Seplou (Zhuhai) Co., Ltd. · Class II
Cleared under the same submission
K172527 also covers:
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Cook — COOK INCORPORATED
- Cook — COOK INCORPORATED
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI d3e7925e-79ef-40d3-9a68-4ee0d6e7a5af 37 fields · synced Jun 8, 2026