Selectmucus
FDA 510(k) K954102 · Select Medical Systems, Inc.
510(k) numberK954102
Submission
- Device name
- Selectmucus
- Applicant
- Select Medical Systems, Inc.
Williston, VT, US - Received
- August 31, 1995
- Decision date
- November 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HFC – Aspirator, Endocervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1050
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HFC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K895403 | Aspirette Endocervical AspiratorHFC · Traditional | Unimar, Inc. | 11/29/1989SE |
| 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 |
|---|---|---|
| K012935 | Thecurve, Item 507MFD · Traditional | 10/11/2001SE |
| K974819 | Selectcells(Tm) MiniHHK · Traditional | 03/23/1998SE |
| K954099 | Select IuiMFD · Traditional | 11/22/1995SE |
| K954097 | Selectcells StandardHHK · Traditional | 11/21/1995SE |
| K942922 | Selecta 20/60 Chemistry AnalyzerJJE · Traditional | 07/19/1995SE |
Questions and answers
When was Selectmucus cleared by the FDA?
Selectmucus (K954102) received a 510(k) decision of Substantially Equivalent on November 21, 1995, 82 days after the submission was received.
What is the product code of K954102?
The FDA product code is HFC – Aspirator, Endocervical, a Class II (moderate risk) device regulated under 21 CFR 884.1050.