Cervical Dilators:Pratt,Hawkin,Kleegman,Denniston
FDA 510(k) K930034 · Thomasville Medical Assoc.
510(k) numberK930034
Submission
- Device name
- Cervical Dilators:Pratt,Hawkin,Kleegman,Denniston
- Applicant
- Thomasville Medical Assoc.
Alpharetta, GA, US - Received
- January 5, 1993
- Decision date
- February 24, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| K896701 | Teflon Cervical Access SetHDQ · Traditional | Cook Ob/Gyn | 09/13/1990SE |
| 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 |
More from Cavitron Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K926429 | Vaginal Specula: Cusco, Guttman, InfantHDF · Traditional | 02/28/1994SE |
| 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 |
Questions and answers
When was Cervical Dilators:Pratt,Hawkin,Kleegman,Denniston cleared by the FDA?
Cervical Dilators:Pratt,Hawkin,Kleegman,Denniston (K930034) received a 510(k) decision of Substantially Equivalent on February 24, 1994, 415 days after the submission was received.
What is the product code of K930034?
The FDA product code is HDQ – Dilator, Cervical, Fixed Size, a Class I (low risk) device regulated under 21 CFR 884.4530.