Cleared Traditional

K221504 - BD Surgiphor™ Antimicrobial Irrigation System (FDA 510(k) Clearance)

K221504 · Bd · General & Plastic Surgery device

Oct 2022

Decision

144d

Days

Class 2

Risk

K221504 is an FDA 510(k) clearance for the BD Surgiphor™ Antimicrobial Irrigation System. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).

Submitted by Bd (Vernon Hills, US). The FDA issued a Cleared decision on October 14, 2022, 144 days after receiving the submission on May 23, 2022.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5475.

Submission Details

510(k) Number	K221504 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 23, 2022
Decision Date	October 14, 2022
Days to Decision	144 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF