Identity
- Trade Name
- AED Gold Cystoscope 4mm x 0 Degree Olympus Mount FDA UDI
- Generic Name
- Rigid optical cystoscope FDA UDI
- Device Name
- An endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during cystoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fiberoptic bundle. FDA UDI
- Model / Reference
- 8805A-OLY FDA UDI
- Description
- An endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during cystoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fiberoptic bundle. FDA UDI
Identifiers
- Catalog Number
- 8805A-OLY FDA UDI
- Primary DI / UDI-DI
- 00848657075145 FDA UDI
- 510(k) Number
- K993689 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- GMDN Term
- Rigid optical cystoscope 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
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid optical cystoscope
AED Gold Cystoscope 4mm x 0 Degree Olympus Mount by National Advanced Endoscopy Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Rigid optical cystoscope.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- IEC-Innoview GmbH — INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Cystoscope — SOPRO-COMEG GmbH · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
Cleared under the same submission
K993689 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 56740231-b0ea-483e-83e0-45c73497cfab 36 fields · synced May 29, 2026