Cervical Dilators Pratt,Hawkin,Kleegman,Denn.,Vall
FDA 510(k) K891029 · Zinnanti Surgical Instruments, Inc.
510(k) numberK891029
Submission
- Device name
- Cervical Dilators Pratt,Hawkin,Kleegman,Denn.,Vall
- Applicant
- Zinnanti Surgical Instruments, Inc.
Chatsworth, CA, US - Received
- February 28, 1989
- Decision date
- March 17, 1989
- 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 |
| K896701 | Teflon Cervical Access SetHDQ · Traditional | Cook Ob/Gyn | 09/13/1990SE |
| 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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| 510(k) | Device | Decision |
|---|---|---|
| K925501 | Nylon Coated SpeculaHIB · Traditional | 06/13/1997SE |
| K941458 | Uterine Manipulator/Injector with SpringLKF · Traditional | 01/25/1995SE |
| K941457 | Uterine Injector with SpringLKF · Traditional | 01/24/1995SE |
| K925560 | Zsi Loop, Zsi Ball & Zsi Needle ElectrodesHGI · Traditional | 08/30/1994SE |
| K925960 | Forceps for Laparoscopic Surgery OB/GYN UseHFI · Traditional | 06/07/1994SE |
| K925957 | Scissors for Laparoscopic Surgery OB/GYN UseHFI · Traditional | 06/07/1994SE |
| K926021 | Needle Holders & Access for Lapar Surg-Ob/Gyn UseHET · Traditional | 04/07/1994SE |
| K925958 | Scissor for Laparoscopic Surgery Gu UseGCJ · Traditional | 03/24/1994SE |
| K926181 | Zsi Laparoscopes-General & Plastic SurgeryGCJ · Traditional | 12/17/1993SE |
| K926016 | Needle Holders & Access for Lapar Surg-Gu UseGCJ · Traditional | 11/12/1993SE |
Questions and answers
When was Cervical Dilators Pratt,Hawkin,Kleegman,Denn.,Vall cleared by the FDA?
Cervical Dilators Pratt,Hawkin,Kleegman,Denn.,Vall (K891029) received a 510(k) decision of Substantially Equivalent on March 17, 1989, 17 days after the submission was received.
What is the product code of K891029?
The FDA product code is HDQ – Dilator, Cervical, Fixed Size, a Class I (low risk) device regulated under 21 CFR 884.4530.