510(k) K000180 ยท HIF Insufflator, Laparoscopic
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
| Applicant | Richard Wolf Medical Instruments Corp., Vernon Hills IL, US |
| Decision | Substantially Equivalent, Mar 2, 2001 |
| Received | Jan 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000180
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2020 | Richard Wolf GmbH Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and access Terminated |
HIF | None listed |
| Mar 11, 2018 | Richard Wolf GmbH RICHARD WOLF TUBE SET FOR TEM, REF 4170.801.
Used for the transanal endoscopic microsurgery. Terminated |
HIF | None listed |
| Aug 24, 2006 | Richard Wolf Medical Instruments Corp. Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring tube, an insufflation tube, an irrigation tube, a suction tube, a pump tube, and a connection tube; a sterile, Terminated |
HIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.