Identity
- Trade Name
- PENTAX Medical FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
- Device Name
- PENTAX Medical PROfILE Single-Use Cleaning Brush FDA UDI
- Model / Reference
- CS-C11A FDA UDI
- Description
- PENTAX Medical PROfILE Single-Use Cleaning Brush FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14961333221650 FDA UDI
- 510(k) Number
- K172156 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical instrument/endoscope cleaning utensil, single-use
PENTAX Medical by Hoya Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument/endoscope cleaning utensil, single-use.
- Cleaning Brushes — ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. · Class I
- Cleaning brushes — SANDERSON MACLEOD · Class I
- Cleaning Brushes for Endoscope — Changzhou Jiuhong Medical Instrument Co., Ltd. · Class I
- Cleaning Brushes for Endoscope — Changzhou Jiuhong Medical Instrument Co., Ltd. · Class I
- Cleaning Brushes — ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. · Class I
- Cleaning brush — H.+H. Maslanka Chirurgische Instrumente GmbH · Class I
- Cleaning brush — H.+H. Maslanka Chirurgische Instrumente GmbH · Class I
- Cleaning brushes — SANDERSON MACLEOD · Class I
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 0479a79a-a24f-4190-9bed-857b7ab43f9d 34 fields · synced May 30, 2026