Hayes Vaginal Shield
FDA 510(k) K862478 · Franklin Medical USA, Inc.
510(k) numberK862478
Submission
- Device name
- Hayes Vaginal Shield
- Applicant
- Franklin Medical USA, Inc.
Southfield, MI, US - Received
- June 30, 1986
- Decision date
- November 24, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HDF – Speculum, Vaginal, Metal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4520
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HDF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K926429 | Vaginal Specula: Cusco, Guttman, InfantHDF · Traditional | Thomasville Medical Assoc. | 02/28/1994SE |
| K902019 | Modified Metal Speculum & Special Bullet ForcepsHDF · Traditional | Gynescope Corp. | 06/07/1990SE |
| K891041 | Miya SpeculumHDF · Traditional | Zinnanti Surgical Instruments, Inc. | 03/22/1989SE |
| K891044 | Laser SpeculaHDF · Traditional | Zinnanti Surgical Instruments, Inc. | 03/17/1989SE |
| K890375 | Vaginal SpeculumHDF · Traditional | Kinetic Medical Products | 02/13/1989SE |
| K853640 | Wellington Hospital Pattern Self Retaining VaginalHDF · Traditional | Downs Surgical , Ltd. | 10/29/1985SE |
| K851799 | 61-100 to 61-124 Various Vaginal Specvia(Cusco,GraHDF · Traditional | Artiberia | 05/22/1985SE |
| K843388 | Wellington Hospital Pattern Self-RetainHDF · Traditional | Downs Surgical , Ltd. | 10/01/1984SE |
| K821297 | Graves SpeculaHDF · Traditional | Conphar, Inc. | 05/24/1982SE |
| K821291 | Pederson Vaginal SpeculaHDF · Traditional | Conphar, Inc. | 05/24/1982SE |
More from Conphar, Inc.
Questions and answers
When was Hayes Vaginal Shield cleared by the FDA?
Hayes Vaginal Shield (K862478) received a 510(k) decision of Substantially Equivalent on November 24, 1986, 147 days after the submission was received.
What is the product code of K862478?
The FDA product code is HDF – Speculum, Vaginal, Metal, a Class I (low risk) device regulated under 21 CFR 884.4520.