TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
FDA 510(k) clearance K000180 · decided 2001-03-02
Clearance details
- K-number
- K000180
- Device name
- TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
- Applicant
- Richard Wolf Medical Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-01-20
- Decision date
- 2001-03-02
- Days to decision
- 407 days
- Clearance type
- Traditional
- Product code
- HIF
- Device class
- 2
- Regulation number
- 884.1730
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Vernon Hills, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination syst recall (Z-2706-2020) | Richard Wolf GmbH | 2020-07-27 |
| Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring t recall (Z-1430-06) | Richard Wolf Medical Instruments Corp. | 2006-08-24 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S002) | Richard Wolf Medical Instruments Corp. | 2016-10-14 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S001) | Richard Wolf Medical Instruments Corp. | 1998-03-12 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080) | Richard Wolf Medical Instruments Corp. | 1996-09-05 |
| RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300 (P890013) | Richard Wolf Medical Instruments Corp. | 1991-09-09 |