Olympus BF Type UC160-OL8
FDA 510(k) K042140 · Olympus Corporation
510(k) numberK042140
Submission
- Device name
- Olympus BF Type UC160-OL8
- Applicant
- Olympus Corporation
Melville, NY, US - Received
- August 9, 2004
- Decision date
- August 18, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- ODG – Endoscopic Ultrasound System, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To provide ultrasonic visualization of body cavities that can be accessed by endoscope. 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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| K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)ODG · Traditional | Olympus Medical Systems Corporation | 10/03/2025SE |
| K251542 | InstaFANODG · Traditional | Onepass Medical , Ltd. | 07/18/2025SE |
| K231813 | Ultrasonic GastrovideoscopeODG · Traditional | Sonoscape Medical Corp. | 03/08/2024SE |
| K232518 | EndoSound Vision System; EVSODG · Traditional | Endosound, Inc. | 12/27/2023SE |
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| K221238 | FUJIFILM Ultrasonic Endoscope EG-740UTODG · Traditional | Fujifilm Corporation | 08/19/2022SE |
| K221952 | Endoscope Model EG-580UT and Endoscope Model EG-580URODG · Special | Fujifilm Corporation | 08/04/2022SE |
| K214089 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2ODG · Traditional | Fujifilm Corporation | 06/03/2022SE |
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Questions and answers
When was Olympus BF Type UC160-OL8 cleared by the FDA?
Olympus BF Type UC160-OL8 (K042140) received a 510(k) decision of Substantially Equivalent on August 18, 2004, 9 days after the submission was received.
What is the product code of K042140?
The FDA product code is ODG – Endoscopic Ultrasound System, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.