GF-UE160-AL5 Ultrasound Endoscope
FDA 510(k) K051541 · Olympus America, Inc.
510(k) numberK051541
Submission
- Device name
- GF-UE160-AL5 Ultrasound Endoscope
- Applicant
- Olympus America, Inc.
Melville, NY, US - Received
- June 10, 2005
- Decision date
- July 1, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FDF – Colonoscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K261015 | Solo Scope Colonoscope SystemFDF · Traditional | Gi View, Ltd. | 08/21/2026SE |
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| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL)FDF · Traditional | Pentax of America, Inc. | 01/03/2025SE |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsFDF · Traditional | Actuated Medical, Inc. | 10/04/2024SE |
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Questions and answers
When was GF-UE160-AL5 Ultrasound Endoscope cleared by the FDA?
GF-UE160-AL5 Ultrasound Endoscope (K051541) received a 510(k) decision of Substantially Equivalent on July 1, 2005, 21 days after the submission was received.
What is the product code of K051541?
The FDA product code is FDF – Colonoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.