SINGLE USE REPOSITIONABLE CLIP
FDA 510(k) clearance K123601 · decided 2013-04-29
Clearance details
- K-number
- K123601
- Device name
- SINGLE USE REPOSITIONABLE CLIP
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2012-11-21
- Decision date
- 2013-04-29
- Days to decision
- 159 days
- Clearance type
- Traditional
- Product code
- PKL
- Device class
- 2
- Regulation number
- 876.4400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal c recall (Z-1987-2023) | Olympus Corporation of the Americas | 2023-06-21 |
| Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal cli recall (Z-1988-2023) | Olympus Corporation of the Americas | 2023-06-21 |
| Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal c recall (Z-1989-2023) | Olympus Corporation of the Americas | 2023-06-21 |
| Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal cli recall (Z-1990-2023) | Olympus Corporation of the Americas | 2023-06-21 |