STRYKER HEATED INSUFFLATOR TUBE SET— 510(k) K003792
Substantially EquivalentStryker Corp.
FDA 510(k) clearance K003792 for STRYKER HEATED INSUFFLATOR TUBE SET, Substantially Equivalent on 2001-02-21. Applicant: Stryker Corp.. Device class: 2.
Clearance details
- Applicant
- Stryker Corp.
- Product code
- Code HIF
- Device class
- Class 2
- Regulation
- 21 CFR 884.1730
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
Recent devices under product code HIF
view allMore clearances from Stryker Corp.
view allAdverse events under product code HIF
product code HIF- Death
- 19
- Injury
- 578
- Malfunction
- 5,639
- Total
- 6,236
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 K003792
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K003792.
Data sourced from openFDA. This site is unofficial and independent of the FDA.