BOWEN SUTURE PASSER
Device Facts
| Record ID | K863146 |
|---|---|
| Device Name | BOWEN SUTURE PASSER |
| Applicant | Bowen & Company, Inc. |
| Product Code | HXI · Orthopedic |
| Decision Date | Sep 5, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.4540 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
