ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS— 510(k) K922391
Substantially EquivalentInstratek, Inc.
FDA 510(k) clearance K922391 for ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS, Substantially Equivalent on 1992-08-18. Applicant: Instratek, Inc.. Device class: 2.
Clearance details
- Applicant
- Instratek, Inc.
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
Recent devices under product code HRX
view allMore clearances from Instratek, Inc.
view allAdverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
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 →
Recalls naming K922391
K-number listed on FDA's recall record- Z-1848-2019 — Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1
- Z-1849-2019 — Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K922391.
Data sourced from openFDA. This site is unofficial and independent of the FDA.