Aspirator, Endocervical
The Endocervical Aspirator is a device used to aspirate mucus, cells, or fluid from the endocervical canal, typically for cytological sampling or diagnostic specimen collection. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HFC, regulated under 21 CFR 884.1050, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- HFC
- Device Class
- FDA class 2
- Regulation Number
- 884.1050
- 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 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K974032 | ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR | Dec 22, 1997 | Substantially Equivalent | A & A Medical, Inc. |
| K960263 | CERVICAL MUCOUS ASPIRATION CATHETER | Aug 29, 1996 | Substantially Equivalent | Cook Urological, Inc. |
| K954903 | PEDI VAGINAL ASPIRATOR | Apr 29, 1996 | Substantially Equivalent | Cook Urological, Inc. |
| K954102 | SELECTMUCUS | Nov 21, 1995 | Substantially Equivalent | Select Medical Systems, Inc. |
| K902242 | ENDOCERVICAL ASPIRATOR | Oct 09, 1990 | Substantially Equivalent | Innovative Medical Products, Inc. |
| K902032 | O. B. PACK IV | Sep 28, 1990 | Substantially Equivalent | Customed, Inc. |
| K902954 | OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) | Aug 23, 1990 | Substantially Equivalent | Permobil AB |
| K895403 | ASPIRETTE ENDOCERVICAL ASPIRATOR | Nov 29, 1989 | Substantially Equivalent | Unimar, Inc. |
| K821134 | DC PACK TM | Jun 22, 1982 | Substantially Equivalent | Seamless Hospital Products Co. |
| K812175 | ENDOCERVICAL ASPIRATOR | Sep 21, 1981 | Substantially Equivalent | Fertility Instrumentation, Inc. |
| K801238 | ACCU-PAP T ZONE SAMPLER | Aug 12, 1980 | Substantially Equivalent | Robert Hasselbrack, M.D. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.