Identity
- Trade Name
- ACCESS 15 FDA UDI
- Generic Name
- Endoscopic device remote control FDA UDI
- Device Name
- REMOTE CONTROL ACCESS 15 PUMP FDA UDI
- Model / Reference
- 7205797 FDA UDI
- Description
- REMOTE CONTROL ACCESS 15 PUMP FDA UDI
Identifiers
- Catalog Number
- 7205797 FDA UDI
- Primary DI / UDI-DI
- 03596010441522 FDA UDI
- 510(k) Number
- K000153 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Endoscopic device remote control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscopic device remote control
Access 15 by Smith & Nephew, Inc. — 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
- PENTAX — HOYA CORPORATION · Class II
- ENDOCAM — Richard Wolf GmbH · 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
K000153 also covers:
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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 0a2aaa42-3339-4d45-8bd2-eda5dda8ed42 36 fields · synced Jun 8, 2026