510(k) K243799
- Device
- Fetal Pillow
- Applicant
- CooperSurgical, Inc.
- 510(k) number
- K243799
- Product code
- PWB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-29
- Date received
- 2024-12-11
- Regulation
- 884.4350
- Classification name
- Fetal Head Elevator
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Irina Fedorov
- Address
- 95 Corporate Dr. Trumbull CT US 06611 06611
FDA Registration Numbers#
- 1216677
- 3014195785
Source Documents#
Other 510(k) Records For Product Code PWB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN150053 | FETAL PILLOW | Safe Obstetric Systems, Ltd. | 2017-07-27 |