INSUFFLATION TUBING STERILE AND NON-STERILE
Device Facts
| Record ID | K935639 |
|---|---|
| Device Name | INSUFFLATION TUBING STERILE AND NON-STERILE |
| Applicant | Charles Polo & Co., Inc. |
| Product Code | HIF · Obstetrics/Gynecology |
| Decision Date | Mar 17, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.1730 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.
