Product Code: HFD
FDA class 2
21 CFR 884.1185
Washer, Endometrial
Obstetrics/Gynecology
The Endometrial Washer is a device used to irrigate the uterine cavity and collect the washings for cytological analysis, providing a method of sampling endometrial cells to screen for or detect endometrial pathology. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HFD, regulated under 21 CFR 884.1185, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
8
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Basic Information
- Product Code
- HFD
- Device Class
- FDA class 2
- Regulation Number
- 884.1185
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K891037 | WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE | Mar 17, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K890376 | VAGINAL SPECULUM | Feb 27, 1989 | Substantially Equivalent | Kinetic Medical Products |
| K810558 | SKIN SCRUB TRAY | Mar 17, 1981 | Substantially Equivalent | Associated Medical Products Co. |