Qualification of a new supplier of the trocar knife (part number 004556-503) to assure that it will continue to meet the previously approved specifications for this component. The trocar knife is currently supplied by xl precision and was proposed to be supplied by the new supplier rms surgical
| Device | Trocar Knife |
| Generic Name | Laparoscopic Contraceptive Tubal Occlusion Device |
| Applicant | Gyrus ACMI, Inc. |
| Date Received | 2020-01-13 |
| Decision Date | 2020-02-12 |
| PMA | P870076 |
| Supplement | S024 |
| Product Code | KNH |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Gyrus ACMI, Inc. 136 Turnpike Rd. southborough, MA 01772 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P870076 | | Original Filing |
| S027 |
2021-04-21 |
30-day Notice |
| S026 |
2021-04-16 |
Special (immediate Track) |
| S025 |
2020-04-03 |
30-day Notice |
| S024 |
2020-01-13 |
30-day Notice |
| S023 |
2016-07-18 |
Real-time Process |
| S022 |
2016-03-24 |
Normal 180 Day Track No User Fee |
| S021 |
2016-02-04 |
30-day Notice |
| S020 |
2016-01-13 |
30-day Notice |
| S019 |
2015-12-28 |
30-day Notice |
| S018 |
2015-12-08 |
Normal 180 Day Track No User Fee |
| S017 |
2015-11-02 |
Normal 180 Day Track |
| S016 |
2015-01-22 |
30-day Notice |
| S015 |
2014-11-05 |
30-day Notice |
| S014 |
2014-10-20 |
Special (immediate Track) |
| S013 |
2012-10-04 |
Special (immediate Track) |
| S012 |
2012-06-05 |
30-day Notice |
| S011 |
2010-06-15 |
30-day Notice |
| S010 |
2010-05-04 |
30-day Notice |
| S009 |
2010-01-27 |
30-day Notice |
| S008 |
2006-08-18 |
Normal 180 Day Track No User Fee |
| S007 |
1998-07-27 |
Normal 180 Day Track |
| S006 |
1997-03-11 |
Normal 180 Day Track |
| S005 |
1996-11-27 |
Normal 180 Day Track |
| S004 |
1996-02-07 |
Normal 180 Day Track |
| S003 |
1995-10-05 |
Normal 180 Day Track |
| S002 | | |
| S001 |
1995-09-01 |
Normal 180 Day Track |
NIH GUDID Devices