The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Transanal Endoscopic Microsurgery (tem) Combination System And Instrument Set, Instrument Set For The Transanal Endoscop.
| Device ID | K000180 |
| 510k Number | K000180 |
| Device Name: | TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP |
| Classification | Insufflator, Laparoscopic |
| Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Contact | Robert L Casarsa |
| Correspondent | Robert L Casarsa RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Product Code | HIF |
| Subsequent Product Code | FJL |
| Subsequent Product Code | GCM |
| Subsequent Product Code | KNS |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-20 |
| Decision Date | 2001-03-02 |