| Device Type ID | 4040 |
| Device Name | Tubing/tubing With Filter, Insufflation, Laparoscopic |
| Regulation Description | Laparoscopic 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 | 884.1730 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NKC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4040 |
| Device | Tubing/tubing With Filter, Insufflation, Laparoscopic |
| Product Code | NKC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Laparoscopic Insufflator. |
| CFR Regulation Number | 884.1730 [🔎] |
| Device Problems | |
|---|---|
Infusion Or Flow Problem | 8 |
Device Operates Differently Than Expected | 4 |
No Flow | 3 |
Kinked | 3 |
Inaccurate Flow Rate | 2 |
Material Distortion | 1 |
Improper Flow Or Infusion | 1 |
| Total Device Problems | 22 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Karl Storz Endoscopy | II | Nov-16-2017 |