Definition: A Gynecologic Laparoscope Is A Device Used To Permit Direct Viewing Of The Organs Within The Peritoneum By A Telescopic System Introduced Through The Abdominal Wall. It Is Used To Perform Diagnostic And Surgical Procedures On The Female Genital Organ
| Device Type ID | 4042 |
| Device Name | Laparoscope And Accessories, Gynecologic, Reprocessed |
| Regulation Description | Gynecologic Laparoscope And Accessories. |
| 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 | 884.1720 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NMH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4042 |
| Device | Laparoscope And Accessories, Gynecologic, Reprocessed |
| Product Code | NMH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gynecologic Laparoscope And Accessories. |
| CFR Regulation Number | 884.1720 [🔎] |