Passer
An orthopedic passer is a handheld instrument used to thread or guide sutures, wires, or cables around or through bone and tissue structures during orthopedic repair procedures. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating minimal risk subject to general controls. Product code HWQ falls under the Orthopedic medical specialty.
Research product code HWQ in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HWQ
- Device Class
- FDA class 1
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K970360 | MITEK SUTURE RETROGRADER | Mar 10, 1997 | Substantially Equivalent | Mitek Products |
| K923381 | SOFT TISSUE EXPANDER | May 05, 1993 | Substantially Equivalent | Acufex Microsurgical, Inc. |
| K920621 | ACUFEX PASSING PINS AND SURGICAL WIRE | May 05, 1993 | Substantially Equivalent | Acufex Microsurgical, Inc. |
| K885311 | MENISCUS MENDER II LOOP | Feb 09, 1989 | Substantially Equivalent | Instrument Makar, Inc. |
| K843592 | VICO MICRO SURGICAL INSTRUMENTS | Oct 05, 1984 | Substantially Equivalent | Visitec Co. |
| K841623 | SLOTTED SOFT-TISSUE INSTRUMENT | Jul 11, 1984 | Substantially Equivalent | Plastafil, Inc. |
| K841622 | SOFT-TISSUE INSTRUMENT | Jul 11, 1984 | Substantially Equivalent | Plastafil, Inc. |
| K811679 | SILASTIC TENDON PASSER H.P. | Jul 10, 1981 | Substantially Equivalent | Dow Corning Corp. Healthcare Industries Materials |
| K791960 | ROTH-KENNEDY PASSER | Oct 04, 1979 | Substantially Equivalent | 3M Company |
FEI Numbers
This FDA classification entry is associated with 130 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 130 registration numbers. Click on an entry to view related FDA registrations.