Teflon Cervical Access Set
FDA 510(k) K896701 · Cook Ob/Gyn
510(k) numberK896701
Submission
- Device name
- Teflon Cervical Access Set
- Applicant
- Cook Ob/Gyn
Spencer, IN, US - Received
- November 28, 1989
- Decision date
- September 13, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HDQ – Dilator, Cervical, Fixed Size
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HDQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K930034 | Cervical Dilators:Pratt,Hawkin,Kleegman,DennistonHDQ · Traditional | Thomasville Medical Assoc. | 02/24/1994SE |
| K891029 | Cervical Dilators Pratt,Hawkin,Kleegman,Denn.,VallHDQ · Traditional | Zinnanti Surgical Instruments, Inc. | 03/17/1989SE |
| K890377 | Fixed-Size Uterine DilatorHDQ · Traditional | Kinetic Medical Products | 02/13/1989SE |
| K811568 | Cervical DilatorHDQ · Traditional | Gynemetrics, Inc. | 07/16/1981SE |
| K791277 | Model 6500 Extraction Irrigation SysHDQ · Traditional | Cavitron Corp. | 08/22/1979SE |
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Questions and answers
When was Teflon Cervical Access Set cleared by the FDA?
Teflon Cervical Access Set (K896701) received a 510(k) decision of Substantially Equivalent on September 13, 1990, 289 days after the submission was received.
What is the product code of K896701?
The FDA product code is HDQ – Dilator, Cervical, Fixed Size, a Class I (low risk) device regulated under 21 CFR 884.4530.