Definition: Tubing And Tubing/filter Fits Are Used When There Is A Need To Distend The Uterus By Filling The Uterine Cavity With A Liquid Or Gas To Facilitate Viewing With A Hysteroscope.
| Device Type ID | 4049 |
| Device Name | Tubing And Tubing/filter Fits |
| Physical State | Tubing And Tubing/filter Fits Which Only Include Accessory Instruments That Are Not Used To Effect Intrauterine Access, E.g., Hysteroscopic Introducer Sheaths, Etc.; And Single-use Tubing Kits Used For Only Intrauterine Insufflation. |
| Technical Method | Tubing And Tubing/filter Fits Which Only Include Accessory Instruments That Are Not Used To Effect Intrauterine Access |
| Target Area | Distend The Uterine Cavity |
| Regulation Description | Hysteroscopic Insufflator. |
| 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) Exempt |
| CFR Regulation Number | 884.1700 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NVT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4049 |
| Device | Tubing And Tubing/filter Fits |
| Product Code | NVT |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Hysteroscopic Insufflator. |
| CFR Regulation Number | 884.1700 [🔎] |