TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
Device Facts
| Record ID | K000180 |
|---|---|
| Device Name | TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP |
| Applicant | Richard Wolf Medical Instruments Corp. |
| Product Code | HIF · Obstetrics/Gynecology |
| Decision Date | Mar 2, 2001 |
| 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.
