KIMGUARD ONE STEP STERILIZATION WRAP— 510(k) K141712
Substantially EquivalentHalyard Health
FDA 510(k) clearance K141712 for KIMGUARD ONE STEP STERILIZATION WRAP, Substantially Equivalent on 2014-12-18. Applicant: Halyard Health. Device class: 2.
Clearance details
- Applicant
- Halyard Health
- Product code
- Code FRG
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code FRG
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- K161232 — ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit
- K160709 — HALYARD* PURPLE NITRILE XTRA* Powder-Free Exam Gloves
- K153708 — Halyard Black-Orange Powder-Free Nitrile Exam Glove
Adverse events under product code FRG
product code FRG- Other
- 3
- Total
- 3
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.