510(k) K981260
- Device
- KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M
- Applicant
- CLINICAL INNOVATIONS, INC.
- 510(k) number
- K981260
- Product code
- HDB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-09-22
- Date received
- 1998-04-06
- Regulation
- 884.4340
- Classification name
- Extractor, Vacuum, Fetal
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WM D WALLACE
- Address
- 6477 S. Cottonwood St. Murray UT US 84107 84107
FDA Registration Numbers#
- 1216677
- 1722684
- 8022978
- 3014755376
- 1928237
- 1718873
- 9611174
- 3004464325
- 2246552
- 3004378299
- 3008837339
- 1319639
- 3011050570
- 1720929
- 2032098
- 3002807523
Source Documents#
Other 510(k) Records For Product Code HDB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) | Clinical Innovations, LLC | 2025-10-08 |
| K041579 | MEDELA SINGLE USE SILC CUP, MODEL 077.0791 | Medela AG | 2005-04-21 |
| K043614 | VACULINK, MODEL VCL 3000 | Medevco, Inc. | 2005-04-14 |
| K021193 | FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 | Fortune Medical Instrument Corp. | 2003-02-12 |
| K020447 | MITYVAC MERLIN, MODEL 10027 | Prism Enterprises, Inc. | 2002-04-12 |
| K013460 | SWIFT LOW PROFILE CUP (PRO CUP) | Swift Delivery Products | 2002-01-17 |
| K011532 | MITYVAC | Prism Enterprises, Inc. | 2001-07-30 |
| K980976 | AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP | Hollister, Inc. | 1998-08-21 |
| K980212 | MITYVAC | Prism Technologies, Inc. | 1998-07-09 |
| K973942 | SWIFT DELIVERY PRODUCT #300 | Swift Delivery Products | 1997-12-12 |
| K970170 | SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE | Richard G. Lindsay | 1997-03-28 |
| K963287 | VACUUM CUP (004SD) | Swift Delivery Products | 1996-10-28 |
| K960549 | MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE | Neward Enterprises, Inc. | 1996-08-29 |
| K942725 | CMI VELVET TOUCH VACUUM EXTRACTOR | Columbia Medical & Surgical, Inc. | 1995-05-05 |
| K943938 | MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE | Neward Enterprises, Inc. | 1995-05-03 |
Legacy Summary#
summary
FDA Review#
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