Identity
- Trade Name
- AED HS5400-BP Bipolar Hystero-Resectoscope Set FDA UDI
- Generic Name
- Resectoscope FDA UDI
- Device Name
- An endoscope with a slender rigid inserted portion, which consists of an outer sheath, a wide angle telescope, a working guide element and a variety of interchangeable electrosurgical electrodes such as a wire loop, knife, roller ball, ball and coagulating. FDA UDI
- Model / Reference
- HS5400-BP FDA UDI
- Description
- An endoscope with a slender rigid inserted portion, which consists of an outer sheath, a wide angle telescope, a working guide element and a variety of interchangeable electrosurgical electrodes such as a wire loop, knife, roller ball, ball and coagulating. FDA UDI
Identifiers
- Catalog Number
- HS5400-BP FDA UDI
- Primary DI / UDI-DI
- 00848657074919 FDA UDI
- 510(k) Number
- K141515 FDA UDI
- FDA Product Code
- HIH FDA UDI
- GMDN Term
- Resectoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 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
Moist Heat or Steam Sterilization FDA UDI
Category: Resectoscope
AED HS5400-BP Bipolar Hystero-Resectoscope Set by National Advanced Endoscopy Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Resectoscope.
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class II
- E-LINE — Richard Wolf GmbH · Class II
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class II
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class II
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class II
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class II
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class II
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
Cleared under the same submission
K141515 also covers:
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, 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
- National Advanced Endoscopy Devices, Inc.
Sources (1)
- FDA UDI 1b657650-e00c-4524-bf9c-020a13f6bd79 36 fields · synced Jun 8, 2026