FDA Product Code
FDA Product Code HWQ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.4540
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K970360 | MITEK SUTURE RETROGRADER | Mitek Products | 1997-03-10 | Traditional | PDF ↗ |
| K920621 | ACUFEX PASSING PINS AND SURGICAL WIRE | Acufex Microsurgical, Inc. | 1993-05-05 | Traditional | PDF ↗ |
| K923381 | SOFT TISSUE EXPANDER | Acufex Microsurgical, Inc. | 1993-05-05 | Traditional | PDF ↗ |
| K885311 | MENISCUS MENDER II LOOP | Instrument Makar, Inc. | 1989-02-09 | Traditional | PDF ↗ |
| K843592 | VICO MICRO SURGICAL INSTRUMENTS | Visitec Co. | 1984-10-05 | Traditional | PDF ↗ |
| K841622 | SOFT-TISSUE INSTRUMENT | Plastafil, Inc. | 1984-07-11 | Traditional | PDF ↗ |
| K841623 | SLOTTED SOFT-TISSUE INSTRUMENT | Plastafil, Inc. | 1984-07-11 | Traditional | PDF ↗ |
| K811679 | SILASTIC TENDON PASSER H.P. | Dow Corning Corp. Healthcare Industries Materials | 1981-07-10 | Traditional | PDF ↗ |
| K791960 | ROTH-KENNEDY PASSER | 3M Company | 1979-10-04 | Traditional | PDF ↗ |
Product code HWQ · Class I · Orthopedic. Data: openFDA.