OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
FDA 510(k) clearance K984358 · decided 1999-09-17
Clearance details
- K-number
- K984358
- Device name
- OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-12-07
- Decision date
- 1999-09-17
- Days to decision
- 284 days
- Clearance type
- Traditional
- Product code
- FDS
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the recall (Z-2522-2023) | Aomori Olympus Co., Ltd. | 2023-09-07 |
| Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587 recall (Z-2523-2023) | Aomori Olympus Co., Ltd. | 2023-09-07 |