Vaginal Specula: Cusco, Guttman, Infant
FDA 510(k) K926429 · Thomasville Medical Assoc.
510(k) numberK926429
Submission
- Device name
- Vaginal Specula: Cusco, Guttman, Infant
- Applicant
- Thomasville Medical Assoc.
Alpharetta, GA, US - Received
- December 23, 1992
- Decision date
- February 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
| K862478 | Hayes Vaginal ShieldHDF · Traditional | Franklin Medical USA, Inc. | 11/24/1986SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K930030 | Suction Tubes: House, BaronJCX · Traditional | 02/25/1994SE |
| K926540 | Sopher and Bierer Ovum ForcepsHLZ · Traditional | 02/25/1994SE |
| K926536 | Disposable Plastic Vaginal SpeculaHIB · Traditional | 02/25/1994SE |
| K926535 | Gomco Circumcision ClampHFX · Traditional | 02/25/1994SE |
| K926533 | Z-Clamp ForcepsHCZ · Traditional | 02/25/1994SE |
| K926532 | Endo Cervical CuretteKNA · Traditional | 02/25/1994SE |
| K926531 | Hysterectomy ForcepsHCZ · Traditional | 02/25/1994SE |
| K926527 | Roto Fit Biopsy ForcepsHFB · Traditional | 02/25/1994SE |
| K926484 | Corson Myoma Grasping ForcepsHCZ · Traditional | 02/25/1994SE |
| K926471 | Mogan Circumcision ClampHFX · Traditional | 02/25/1994SE |
Questions and answers
When was Vaginal Specula: Cusco, Guttman, Infant cleared by the FDA?
Vaginal Specula: Cusco, Guttman, Infant (K926429) received a 510(k) decision of Substantially Equivalent on February 28, 1994, 432 days after the submission was received.
What is the product code of K926429?
The FDA product code is HDF – Speculum, Vaginal, Metal, a Class I (low risk) device regulated under 21 CFR 884.4520.