Olympus Endoarm
FDA 510(k) K043128 · Olympus Corporation
510(k) numberK043128
Submission
- Device name
- Olympus Endoarm
- Applicant
- Olympus Corporation
Melville, NY, US - Received
- November 12, 2004
- Decision date
- December 21, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- GWG – Endoscope, Neurological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1480
- Specialty
- Neurology
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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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| K222735 | HJY VisualNext Endoscopic Vision SystemGWG · Traditional | Hjy Smart Medical Device Co., Ltd. | 07/28/2023SE |
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Questions and answers
When was Olympus Endoarm cleared by the FDA?
Olympus Endoarm (K043128) received a 510(k) decision of Substantially Equivalent on December 21, 2004, 39 days after the submission was received.
What is the product code of K043128?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.