Dilator, Cervical, Fixed Size
The Fixed-Size Cervical Dilator is a manually operated gynecological instrument used to mechanically widen the cervical opening to facilitate procedures such as intrauterine device insertion, biopsy, or dilation and curettage. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from the 510(k) premarket notification requirement. The product code is HDQ, regulated under 21 CFR 884.4530, within the Obstetrics/Gynecology specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HDQ
- Device Class
- FDA class 1
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K930034 | CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTON | Feb 24, 1994 | Substantially Equivalent | Thomasville Medical Assoc. |
| K896701 | TEFLON CERVICAL ACCESS SET | Sep 13, 1990 | Substantially Equivalent | Cook Ob/Gyn |
| K891029 | CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL | Mar 17, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K890377 | FIXED-SIZE UTERINE DILATOR | Feb 13, 1989 | Substantially Equivalent | Kinetic Medical Products |
| K811568 | CERVICAL DILATOR | Jul 16, 1981 | Substantially Equivalent | Gynemetrics, Inc. |
| K791277 | MODEL 6500 EXTRACTION IRRIGATION SYS | Aug 22, 1979 | Substantially Equivalent | Cavitron Corp. |
FEI Numbers
This FDA classification entry is associated with 151 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 151 registration numbers. Click on an entry to view related FDA registrations.