STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES— 510(k) K962800
Substantially EquivalentStryker Instruments
FDA 510(k) clearance K962800 for STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES, Substantially Equivalent on 1996-09-11. Applicant: Stryker Instruments. Device class: 1.
Clearance details
- Applicant
- Stryker Instruments
- Product code
- Product code HWE
- Device class
- Class 1
- Regulation
- 21 CFR 878.4820
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kalamazoo, MI, US
Recent devices under product code HWE
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- K262244 — Sonopet iQ Series III Console (5700-050-000) +6 more
- K261959 — Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100) +3 more
- K261544 — Hydro Irrigation System
- K253679 — Hydro Irrigation System
Adverse events under product code HWE
product code HWE- Death
- 4
- Injury
- 448
- Malfunction
- 19,856
- Other
- 2
- Total
- 20,310
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.