Obstetrical Vacuum Cup
FDA 510(k) K911326 · Gesco Intl., Inc.
510(k) numberK911326
Submission
- Device name
- Obstetrical Vacuum Cup
- Applicant
- Gesco Intl., Inc.
San Antonio, TX, US - Received
- March 26, 1991
- Decision date
- August 14, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HDB – Extractor, Vacuum, Fetal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4340
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HDB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum…HDB · Traditional | Clinical Innovations, LLC | 10/08/2025SE |
| K041579 | Medela Single Use Silc Cup, Model 077.0791HDB · Traditional | Medela AG | 04/21/2005SE |
| K043614 | Vaculink, Model VCL 3000HDB · Traditional | Medevco, Inc. | 04/14/2005SE |
| K021193 | Fortune Silicone Vacuum Suction, Model #1300HDB · Traditional | Fortune Medical Instrument Corp. | 02/12/2003SE |
| K020447 | Mityvac Merlin, Model 10027HDB · Special | Prism Enterprises, Inc. | 04/12/2002SE |
| K013460 | Swift Low Profile Cup (Pro Cup)HDB · Traditional | Swift Delivery Products | 01/17/2002SE |
| K011532 | MityvacHDB · Special | Prism Enterprises, Inc. | 07/30/2001SE |
| K981260 | Kiwi Soft Cup with Palm Pump Model Number VFE-6000S, Kiwi Mushroom Cup with Palm Pump…HDB · Traditional | Clinical Innovations, Inc. | 09/22/1998SE |
| K980976 | Ameda Disposable Vacuum Assist Cup with Fluid Retention TrapHDB · Traditional | Hollister, Inc. | 08/21/1998SE |
| K980212 | MityvacHDB · Traditional | Prism Technologies, Inc. | 07/09/1998SE |
More from Prism Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954422 | Per-Q-Cath Mid-LineLJS · Traditional | 12/15/1995SE |
| K940953 | Umbili-Cath-SFOS · Traditional | 08/02/1994SE |
| K940870 | Umbili-CathFOS · Traditional | 08/02/1994SE |
| K940952 | Umbili-Cath-S-DlFOS · Traditional | 07/29/1994SE |
| K941672 | Uri-Cath CatheterGBM · Traditional | 05/16/1994SE |
| K941232 | Thora-CathJOL · Traditional | 05/11/1994SE |
| K940871 | Umbili-Cath-PFOS · Traditional | 04/29/1994SE |
| K931989 | Ventri-CathJXG · Traditional | 07/21/1993SE |
| K926063 | Per-Q-Cath Dressing Change TrayMCY · Traditional | 06/07/1993SEKD |
| K923591 | Pala-NateBTR · Traditional | 03/16/1993SE |
Questions and answers
When was Obstetrical Vacuum Cup cleared by the FDA?
Obstetrical Vacuum Cup (K911326) received a 510(k) decision of Substantially Equivalent on August 14, 1991, 141 days after the submission was received.
What is the product code of K911326?
The FDA product code is HDB – Extractor, Vacuum, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.4340.