REPROCESSED ENT SHAVERS— 510(k) K081814
Substantially EquivalentSterilmed, Inc.
FDA 510(k) clearance K081814 for REPROCESSED ENT SHAVERS, Substantially Equivalent on 2008-12-17. Applicant: Sterilmed, Inc.. Device class: 2.
Clearance details
- Applicant
- Sterilmed, Inc.
- Product code
- Code ERL
- Device class
- Class 2
- Regulation
- 21 CFR 874.4250
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maple Grove, MN, US
Recent devices under product code ERL
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- K190610 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
- K182272 — Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
Adverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
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.