Olympus Disposable Biopsy Valve
FDA 510(k) K911412 · Olympus Corp.
510(k) numberK911412
Submission
- Device name
- Olympus Disposable Biopsy Valve
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- April 1, 1991
- Decision date
- June 28, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated…
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| K915402 | EW-10 and EW-20FEB · Traditional | 06/23/1995SN |
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Questions and answers
When was Olympus Disposable Biopsy Valve cleared by the FDA?
Olympus Disposable Biopsy Valve (K911412) received a 510(k) decision of Substantially Equivalent on June 28, 1991, 88 days after the submission was received.
What is the product code of K911412?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.