XSTAT 30 Pouch— 510(k) K210676

Substantially Equivalent

Revmedx, Inc.

FDA 510(k) clearance K210676 for XSTAT 30 Pouch, Substantially Equivalent on 2021-08-27. Applicant: Revmedx, Inc.. Device class: 2.

Clearance details

Applicant: Revmedx, Inc.
Product code: Code PGZ
Device class: Class 2
Regulation: 21 CFR 878.4452
Advisory panel: General, Plastic Surgery
Date received: 2021-03-05
Decision date: 2021-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilsonville,, OR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PGZ

K253290 — XSTAT P152025-11-12
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K170334 — XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack2017-05-01
K161020 — XSTAT-12, 3-Pack, XSTAT-12, 1-Pack2016-07-28
K152624 — XSTAT 30, 3-PACK, XSTAT 30, 1-PACK2015-12-07

More clearances from Revmedx, Inc.

DEN130016 — XSTAT2014-04-03

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