Simex Subglottic Aspiration System

FDA 510(k) K141255 · Simex Medizintechnik GmbH

Substantially Equivalent

510(k) numberK141255

Submission

Device name
Simex Subglottic Aspiration System
Applicant
Simex Medizintechnik GmbH
Tarrytown, NY, US
Received
May 14, 2014
Decision date
September 22, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTA – Pump, Portable, Aspiration (Manual Or Powered)
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4780
Specialty
General, Plastic Surgery

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Questions and answers

When was Simex Subglottic Aspiration System cleared by the FDA?

Simex Subglottic Aspiration System (K141255) received a 510(k) decision of Substantially Equivalent on September 22, 2014, 131 days after the submission was received.

What is the product code of K141255?

The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.