STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM— 510(k) K112593
Substantially EquivalentStryker Corporation
FDA 510(k) clearance K112593 for STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM, Substantially Equivalent on 2012-05-01. Applicant: Stryker Corporation. Device class: 2.
Clearance details
- Applicant
- Stryker Corporation
- 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
- Kalamazoo, MI, US
Recent devices under product code ERL
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- K223770 — Sonopet 1Q 3 7cm 1Q Large
- K221728 — Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior Cervical Plating (ACP) System, Reflex Hybrid ACP System, UniVise Spinous Process Fixation Plate
- K221074 — OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device
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.