510(k) K981260 ยท HDB Extractor, Vacuum, Fetal
KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M
| Applicant | Clinical Innovations, Inc., Murray UT, US |
| Decision | Substantially Equivalent, Sep 22, 1998 |
| Received | Apr 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981260
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2026 | Clinical Innovations, LLC Brand Name: Kiwi Omni Vacuum Delivery System
Product Name: Kiwi Omni Vacuum Delivery System
Model/Catalog Number: VAC-6000MT
Product Description: The Clinical Innovations Kiwi is a disposable vacuum Open, Classified |
HDB | None listed |
| Aug 6, 2019 | Clinical Innovations, LLC Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system. Terminated |
HDB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.