Product code HWQ— Orthopedic
ACUFEX PASSING PINS AND SURGICAL WIRE
- Classification name
- Passer
- Device class
- Class 1
- Regulation
- 21 CFR 888.4540
- Advisory panel
- Orthopedic
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code HWQ
FDA has cleared devices under product code HWQ between 1979 and 1997, filed by 7 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1997
- 1993
- 1989
- 1984
- 1981
- 1979
Top applicants under product code HWQ
Adverse events under product code HWQ
product code HWQ- Injury
- 137
- Malfunction
- 443
- Total
- 580
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code HWQ
- K970360 — MITEK SUTURE RETROGRADER
- K920621 — ACUFEX PASSING PINS AND SURGICAL WIRE
- K923381 — SOFT TISSUE EXPANDER
- K885311 — MENISCUS MENDER II LOOP
- K843592 — VICO MICRO SURGICAL INSTRUMENTS
- K841622 — SOFT-TISSUE INSTRUMENT
- K841623 — SLOTTED SOFT-TISSUE INSTRUMENT
- K811679 — SILASTIC TENDON PASSER H.P.
- K791960 — ROTH-KENNEDY PASSER
Data sourced from openFDA. This site is unofficial and independent of the FDA.