Aspirette Endocervical Aspirator
FDA 510(k) K895403 · Unimar, Inc.
510(k) numberK895403
Submission
- Device name
- Aspirette Endocervical Aspirator
- Applicant
- Unimar, Inc.
Wilton, CT, US - Received
- September 7, 1989
- Decision date
- November 29, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HFC – Aspirator, Endocervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1050
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
| K974032 | Rocket Mucus Sampler Syringe, Sterile, Rocket Mucus Sampler Syringe, Clinically AspiratorHFC · Traditional | A & A Medical, Inc. | 12/22/1997SE |
| K960263 | Cervical Mucous Aspiration CatheterHFC · Traditional | Cook Urological, Inc. | 08/29/1996SE |
| K954903 | Pedi Vaginal AspiratorHFC · Traditional | Cook Urological, Inc. | 04/29/1996SE |
| K954102 | SelectmucusHFC · Traditional | Select Medical Systems, Inc. | 11/21/1995SE |
| K902242 | Endocervical AspiratorHFC · Traditional | Innovative Medical Products, Inc. | 10/09/1990SE |
| K902032 | O. B. Pack IVHFC · Traditional | Customed, Inc. | 09/28/1990SE |
| K902954 | OBER2 Monitor, Eye Movement (Ophthalmic)HFC · Traditional | Permobil AB | 08/23/1990SE |
| K821134 | DC Pack TMHFC · Traditional | Seamless Hospital Products Co. | 06/22/1982SE |
| K812175 | Endocervical AspiratorHFC · Traditional | Fertility Instrumentation, Inc. | 09/21/1981SE |
| K801238 | Accu-Pap T Zone SamplerHFC · Traditional | Robert Hasselbrack, M.D. | 08/12/1980SE |
More from Robert Hasselbrack, M.D.
| 510(k) | Device | Decision |
|---|---|---|
| K932432 | Kronner Reinforcing StyletteLKF · Traditional | 04/12/1994SE |
| K920803 | HSG TrayHIB · Traditional | 10/19/1992SEKD |
| K910317 | Uni-Sem(Tm)MFD · Traditional | 05/01/1991SE |
| K904473 | Kronner ManipujectorHES · Traditional | 12/14/1990SE |
| K895659 | Hui Mini-FlexHIG · Traditional | 12/19/1989SE |
| K894264 | KDF-2.3HDR · Traditional | 08/15/1989SE |
| K890848 | Cervex-BrushHHT · Traditional | 05/11/1989SE |
| K854415 | Endometrial PipelleHHK · Traditional | 03/13/1986SE |
| K810291 | Sterile/Disposable HSG TrayEYY · Traditional | 03/18/1981SE |
Questions and answers
When was Aspirette Endocervical Aspirator cleared by the FDA?
Aspirette Endocervical Aspirator (K895403) received a 510(k) decision of Substantially Equivalent on November 29, 1989, 83 days after the submission was received.
What is the product code of K895403?
The FDA product code is HFC – Aspirator, Endocervical, a Class II (moderate risk) device regulated under 21 CFR 884.1050.