Cleared Special

Cytal Wound Particulate

K180776 · Acell, Inc. · General & Plastic Surgery
May 2018
Decision
49d
Days
—
Risk

About This 510(k) Submission

K180776 is an FDA 510(k) clearance for the Cytal Wound Particulate, a Wound Dressing With Animal-derived Material(s), submitted by Acell, Inc. (Columbia, US). The FDA issued a Cleared decision on May 11, 2018, 49 days after receiving the submission on March 23, 2018. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K180776 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2018
Decision Date May 11, 2018
Days to Decision 49 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KGN — Wound Dressing With Animal-derived Material(s)
Device Class —