KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M
FDA 510(k) clearance K981260 · decided 1998-09-22
Clearance details
- K-number
- K981260
- Device name
- KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M
- Applicant
- Clinical Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-06
- Decision date
- 1998-09-22
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- HDB
- Device class
- 2
- Regulation number
- 884.4340
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Murray, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery Syste recall (Z-1945-2026) | Clinical Innovations, LLC | 2026-04-24 |