Basic, Dominant Flex— 510(k) K170329

Substantially Equivalent

Modela AG

FDA 510(k) clearance K170329 for Basic, Dominant Flex, Substantially Equivalent on 2017-03-24. Applicant: Modela AG. Device class: 2.

Clearance details

Applicant: Modela AG
Product code: Code QPB
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2017-02-02
Decision date: 2017-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baar, CH

Download summary PDF View on FDA.gov ↗

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Recalls naming K170329

K-number listed on FDA's recall record

Z-1502-2021 — Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump.Class II·Terminated·Medela AG Medical Technology·20201202

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170329.

Data sourced from openFDA. This site is unofficial and independent of the FDA.