Aspirator, Endometrial
The Endometrial Aspirator is a device used to suction tissue or fluid from the endometrial lining of the uterus for histopathological examination, often employed as a minimally invasive outpatient alternative to dilation and curettage. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HFF, regulated under 21 CFR 884.1060, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- HFF
- Device Class
- FDA class 2
- Regulation Number
- 884.1060
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K041237 | ECHOSAMPLER | Sep 08, 2004 | Substantially Equivalent | Gynetics Medical Products NV |
| K903002 | PROBET (TM) | Apr 05, 1991 | Substantially Equivalent | Gynopharma, Inc. |
| K902693 | WALLACH FLEXIBLE ENDOMETRIAL SAMPLER | Jan 31, 1991 | Substantially Equivalent | Wallach Surgical Devices, Inc. |
| K831212 | ENDOSCANN | Jun 15, 1984 | Substantially Equivalent | Axcan Scientific Corp. |
| K820641 | ACCURETTE | Jun 22, 1982 | Substantially Equivalent | Axcan Scientific Corp. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.