HFC · Aspirator, Endocervical
Obstetrics/Gynecology · 21 CFR 884.1050 · Class 2
Overview
| Product Code | HFC |
|---|---|
| Device Name | Aspirator, Endocervical |
| Regulation | 21 CFR 884.1050 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K974032 | ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR | A & A Medical, Inc. | Dec 22, 1997 | SESE |
| K960263 | CERVICAL MUCOUS ASPIRATION CATHETER | Cook Urological, Inc. | Aug 29, 1996 | SESE |
| K954903 | PEDI VAGINAL ASPIRATOR | Cook Urological, Inc. | Apr 29, 1996 | SESE |
| K954102 | SELECTMUCUS | Select Medical Systems, Inc. | Nov 21, 1995 | SESE |
| K902242 | ENDOCERVICAL ASPIRATOR | Innovative Medical Products, Inc. | Oct 9, 1990 | SESE |
| K902032 | O. B. PACK IV | Customed, Inc. | Sep 28, 1990 | SESE |
| K902954 | OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) | Permobil AB | Aug 23, 1990 | SESE |
| K895403 | ASPIRETTE ENDOCERVICAL ASPIRATOR | Unimar, Inc. | Nov 29, 1989 | SESE |
| K821134 | DC PACK TM | Seamless Hospital Products Co. | Jun 22, 1982 | SESE |
| K812175 | ENDOCERVICAL ASPIRATOR | Fertility Instrumentation, Inc. | Sep 21, 1981 | SESE |
| K801238 | ACCU-PAP T ZONE SAMPLER | Robert Hasselbrack, M.D. | Aug 12, 1980 | SESE |
Top Applicants
- Cook Urological, Inc. — 2 clearances
- A & A Medical, Inc. — 1 clearance
- Customed, Inc. — 1 clearance
- Fertility Instrumentation, Inc. — 1 clearance
- Innovative Medical Products, Inc. — 1 clearance
