Definition: To Deliver Saline And/or Contrast Media To Complete Saline Infusion Sonohysterography And/or Hysterosalpingogram Respectively And To Obtain Endometrial Biopsy
| Device Type ID | 4081 |
| Device Name | Cannula, Injector, Uterine, Endometrial Biopsy |
| Physical State | Cannula That Allows Injection Of Saline And/or Contrast Media And Component That Collects An Endometrial Biopsy Sample |
| Technical Method | Inserted Manually Through The Vagina And Cervix And Into The Uterus; Delivers Saline And/or Contrast Media Into The Uterus And Fallopian Tubes, Collects Endometrial Biopsy Sample |
| Target Area | Uterus, Fallopian Tubes |
| Regulation Description | Obstetric-gynecologic Specialized Manual Instrument. |
| 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 | 884.4530 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PGK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4081 |
| Device | Cannula, Injector, Uterine, Endometrial Biopsy |
| Product Code | PGK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Obstetric-gynecologic Specialized Manual Instrument. |
| CFR Regulation Number | 884.4530 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CROSSBAY MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |