Definition: Obtains Tissue Samples From The Endocervical Canal For Histological Analysis.
| Device Type ID | 4078 |
| Device Name | Sampler, Endocervical |
| Physical State | Handle And Sheath With Collection Tip; Collection Tip Is Designed To Scrape Endocervical Canal And Collect An Endocervical Tissue Sample |
| Technical Method | Inserted Manually Through The Vaginal And Into The Endocervix; Collection Tip Scrapes The Endocervical Canal And Collects Endocervical Tissue Sample |
| Target Area | Cervix |
| Regulation Description | Endocervical Aspirator. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.1050 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PCF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4078 |
| Device | Sampler, Endocervical |
| Product Code | PCF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endocervical Aspirator. |
| CFR Regulation Number | 884.1050 [🔎] |