Solidence Multipockets— 510(k) K191131

Name: FDA 510(k) clearance K191131
Creator: U.S. Food and Drug Administration
Published: 2022-08-03

Substantially Equivalent

Solidence Surgical Corporation

FDA 510(k) clearance K191131 for Solidence Multipockets, Substantially Equivalent on 2022-08-03. Applicant: Solidence Surgical Corporation. Device class: 2.

Clearance details

Applicant: Solidence Surgical Corporation
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2019-04-29
Decision date: 2022-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Fernando, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.