510(k) clearance

SWICS™

FDA 510(k) source

510(k) number

K263459

Applicant

Bloom Surgical, Inc.

Decision date

Oct 29, 2026

Date received

Sep 28, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

GCJ

Device type

Laparoscope, General & Plastic Surgery

Device class

Class II

Regulation

21 CFR 876.1500

Advisory committee

Gastroenterology, Urology

Statement or summary

Summary

Third party

N

Location

Salt Lake City, UT, US