Cleared Traditional

IODOSORB

K190730 · Smith & Nephew Medical, Ltd. · General & Plastic Surgery
Dec 2019
Decision
274d
Days
Risk

About This 510(k) Submission

K190730 is an FDA 510(k) clearance for the IODOSORB, a Dressing, Wound, Drug, submitted by Smith & Nephew Medical, Ltd. (Hull, GB). The FDA issued a Cleared decision on December 20, 2019, 274 days after receiving the submission on March 21, 2019. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K190730 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2019
Decision Date December 20, 2019
Days to Decision 274 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class

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