HWQ · Passer
Orthopedic · 21 CFR 888.4540 · Class 1
Overview
| Product Code | HWQ |
|---|---|
| Device Name | Passer |
| Regulation | 21 CFR 888.4540 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
Cleared Devices (9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K970360 | MITEK SUTURE RETROGRADER | Mitek Products | Mar 10, 1997 | SESE |
| K923381 | SOFT TISSUE EXPANDER | Acufex Microsurgical, Inc. | May 5, 1993 | SESE |
| K920621 | ACUFEX PASSING PINS AND SURGICAL WIRE | Acufex Microsurgical, Inc. | May 5, 1993 | SESE |
| K885311 | MENISCUS MENDER II LOOP | Instrument Makar, Inc. | Feb 9, 1989 | SESE |
| K843592 | VICO MICRO SURGICAL INSTRUMENTS | Visitec Co. | Oct 5, 1984 | SESE |
| K841623 | SLOTTED SOFT-TISSUE INSTRUMENT | Plastafil, Inc. | Jul 11, 1984 | SESE |
| K841622 | SOFT-TISSUE INSTRUMENT | Plastafil, Inc. | Jul 11, 1984 | SESE |
| K811679 | SILASTIC TENDON PASSER H.P. | Dow Corning Corp. Healthcare Industries Materials | Jul 10, 1981 | SESE |
| K791960 | ROTH-KENNEDY PASSER | 3M Company | Oct 4, 1979 | SESE |
Top Applicants
- Plastafil, Inc. — 2 clearances
- Acufex Microsurgical, Inc. — 2 clearances
- Visitec Co. — 1 clearance
- Mitek Products — 1 clearance
- Instrument Makar, Inc. — 1 clearance
