Capio SLIM Suture Capturing Device
FDA 510(k) clearance K172060 · decided 2017-11-03
Clearance details
- K-number
- K172060
- Device name
- Capio SLIM Suture Capturing Device
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2017-07-07
- Decision date
- 2017-11-03
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- PWI
- Device class
- 2
- Regulation number
- 884.4910
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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| Digitex Delivery Device (K173527) | Coloplast A/S | 2018-02-12 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Packag recall (Z-2451-2024) | Boston Scientific Corporation | 2024-07-30 |
| Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Suture Capturing recall (Z-2452-2024) | Boston Scientific Corporation | 2024-07-30 |
| Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturi recall (Z-1616-2018) | Boston Scientific Corporation | 2018-05-04 |
| Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications du recall (Z-1617-2018) | Boston Scientific Corporation | 2018-05-04 |
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