FDA 510(k) Applications Submitted by OPUS MEDICAL, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K004021 |
12/27/2000 |
F1 DIODE LASER SYSTEM |
OPUS MEDICAL, INC. |
| K030170 |
01/17/2003 |
REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 |
OPUS MEDICAL, INC. |
| K031083 |
04/04/2003 |
OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 |
OPUS MEDICAL, INC. |
| K022229 |
07/10/2002 |
SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 |
OPUS MEDICAL, INC. |
| K023843 |
11/18/2002 |
SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE |
OPUS MEDICAL, INC. |
| K020172 |
01/17/2002 |
OPUS MAGNUM ANCHOR & INSTRUMENT SET |
OPUS MEDICAL, INC. |
| K041440 |
06/01/2004 |
OPUS MAGNUM ANCHOR WITH INSERTER |
OPUS MEDICAL, INC. |
| K042031 |
07/28/2004 |
OPUS SPEEDSTITCH SUTURE DEVICE |
OPUS MEDICAL, INC. |
| K042584 |
09/22/2004 |
OPUS MINIMAGNUM ANCHOR WITH INSERTER |
OPUS MEDICAL, INC. |
| K033317 |
10/15/2003 |
SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 |
OPUS MEDICAL, INC. |
| K042914 |
10/21/2004 |
OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE |
OPUS MEDICAL, INC. |
| K012125 |
07/06/2001 |
OPUS MAGNUM ANCHOR & INSERTER |
OPUS MEDICAL, INC. |
| K030235 |
01/23/2003 |
F1 DIODE LASER SYSTEM |
OPUS MEDICAL, INC. |
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