SWICS— 510(k) K263459

Name: FDA 510(k) clearance K263459
Creator: U.S. Food and Drug Administration
Published: 2026-10-29

Substantially Equivalent

Bloom Surgical, Inc.

FDA 510(k) clearance K263459 for SWICS, Substantially Equivalent on 2026-10-29. Applicant: Bloom Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Bloom Surgical, Inc.
Product code: Product code GCJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2026-09-28
Decision date: 2026-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.