Identity
- Trade Name
- PENTAX Medical FDA UDI
- Generic Name
- Endoscopic device remote control FDA UDI
- Device Name
- PENTAX Medical Keyboard EN OS-A94 FDA UDI
- Model / Reference
- OS-A94 FDA UDI
- Description
- PENTAX Medical Keyboard EN OS-A94 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333251636 FDA UDI
- 510(k) Number
- K172156 FDA UDI
- FDA Product Code
- PEA FDA UDI
- GMDN Term
- Endoscopic device remote control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic device remote control
PENTAX Medical by Hoya Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic device remote control.
- REMOTE CONTROL — Olympus Medical Systems Corporation · Class II
- Imaging (ZEOS) — SANTA BARBARA IMAGING SYSTEMS, INC. · Class II
- ENDOCAM — Richard Wolf GmbH · Class II
- DYONICS 25 — Smith & Nephew, Inc. · Class II
- Connected OR HUB — Stryker Corp. · Class II
- OBCU REMOTE CONTROLLER — Olympus Medical Systems Corporation · Class II
- Connected OR HUB — Stryker Corp. · Class II
- Trinity — SANTA BARBARA IMAGING SYSTEMS, INC. · Class II
Cleared under the same submission
K172156 also covers:
- DEFINA — HOYA CORPORATION
- PENTAX — HOYA CORPORATION
- PENTAX — HOYA CORPORATION
- PENTAX — HOYA CORPORATION
- PENTAX — HOYA CORPORATION
- PENTAX — HOYA CORPORATION
- PENTAX — HOYA CORPORATION
- PENTAX Medical — HOYA CORPORATION
- PENTAX Medical — HOYA CORPORATION
- PENTAX Medical — HOYA CORPORATION
- PENTAX Medical — HOYA CORPORATION
- PENTAX Medical — HOYA CORPORATION
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
- Hoya Corporation
Sources (1)
- FDA UDI 3a4b81cc-cb38-41c7-b7d8-a1d444f41cb5 34 fields · synced Jun 8, 2026