FDA Product Code
FDA Product Code HDB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4340
510(k) Clearances — 30 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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 | Traditional | PDF ↗ |
| K041579 | MEDELA SINGLE USE SILC CUP, MODEL 077.0791 | Medela AG | 2005-04-21 | Traditional | PDF ↗ |
| K043614 | VACULINK, MODEL VCL 3000 | Medevco, Inc. | 2005-04-14 | Traditional | PDF ↗ |
| K021193 | FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 | Fortune Medical Instrument Corp. | 2003-02-12 | Traditional | PDF ↗ |
| K020447 | MITYVAC MERLIN, MODEL 10027 | Prism Enterprises, Inc. | 2002-04-12 | Special | PDF ↗ |
| K013460 | SWIFT LOW PROFILE CUP (PRO CUP) | Swift Delivery Products | 2002-01-17 | Traditional | PDF ↗ |
| K011532 | MITYVAC | Prism Enterprises, Inc. | 2001-07-30 | Special | PDF ↗ |
| K981260 | KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M | Clinical Innovations, Inc. | 1998-09-22 | Traditional | PDF ↗ |
| K980976 | AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP | Hollister, Inc. | 1998-08-21 | Traditional | PDF ↗ |
| K980212 | MITYVAC | Prism Technologies, Inc. | 1998-07-09 | Traditional | PDF ↗ |
| K973942 | SWIFT DELIVERY PRODUCT #300 | Swift Delivery Products | 1997-12-12 | Traditional | PDF ↗ |
| K970170 | SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE | Richard G. Lindsay | 1997-03-28 | Traditional | PDF ↗ |
| K963287 | VACUUM CUP (004SD) | Swift Delivery Products | 1996-10-28 | Traditional | PDF ↗ |
| K960549 | MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE | Neward Enterprises, Inc. | 1996-08-29 | Traditional | PDF ↗ |
| K942725 | CMI VELVET TOUCH VACUUM EXTRACTOR | Columbia Medical & Surgical, Inc. | 1995-05-05 | Traditional | PDF ↗ |
| K943938 | MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE | Neward Enterprises, Inc. | 1995-05-03 | Traditional | PDF ↗ |
| K934011 | MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE | Neward Enterprises, Inc. | 1994-05-04 | Traditional | PDF ↗ |
| K913324 | MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT | Neward Enterprises, Inc. | 1992-06-22 | Traditional | PDF ↗ |
| K915763 | MODIFIED DISPOSABLE FETAL VACUUM | Columbia Medical & Surgical, Inc. | 1992-03-18 | Traditional | PDF ↗ |
| K911326 | OBSTETRICAL VACUUM CUP | Gesco Intl., Inc. | 1991-08-14 | Traditional | PDF ↗ |
| K895700 | AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR | Hollister, Inc. | 1990-04-02 | Traditional | PDF ↗ |
| K895446 | CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.) | Challenge Mfg., Inc. | 1989-11-27 | Traditional | PDF ↗ |
| K891465 | OBSTETRIC CUP (MODIFICATION) | Go Medical Industries Pty. , Ltd. | 1989-05-11 | Traditional | PDF ↗ |
| K890307 | MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE | Neward Enterprises, Inc. | 1989-03-31 | Traditional | PDF ↗ |
| K881306 | CMI VACUUM DELIVERY SYSTEM #003C AND #004C | Challenge Mfg., Inc. | 1988-06-13 | Traditional | PDF ↗ |
| K881967 | CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.) | Challenge Mfg., Inc. | 1988-06-13 | Traditional | PDF ↗ |
| K841492 | AB VACUUM EXTRACTOR SILC-CUP | Medela, Inc. | 1984-05-07 | Traditional | PDF ↗ |
| K840008 | O'NEIL OBSTETRIC CUP | Go Medical Industries Pty. , Ltd. | 1984-04-25 | Traditional | PDF ↗ |
| K830012 | MEDELA SUCTION PUMP | Medela, Inc. | 1983-01-24 | Traditional | PDF ↗ |
| K771558 | SILASTIC BRAND OBSTETRICAL VACUUM CUP | Dow Corning Corp. Healthcare Industries Materials | 1977-09-20 | Traditional | PDF ↗ |
Product code HDB · Class II · Obstetrics/Gynecology. Data: openFDA.