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FDA 510(k)

Disposable Pre-calibrated Suction

K-Number: K201752 · 2021-01-29

ApplicantBrainlab AG
Decision Date2021-01-29
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Disposable Pre-calibrated Suction is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2021-01-29 under approval number K201752. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Pre-calibrated Suction?

Disposable Pre-calibrated Suction is a medical device that received FDA 510(k) clearance on 2021-01-29. It is manufactured by Brainlab AG. The 510(k) number is K201752.

When was Disposable Pre-calibrated Suction approved by the FDA?

Disposable Pre-calibrated Suction received FDA 510(k) clearance on 2021-01-29, under approval number K201752.

What company makes Disposable Pre-calibrated Suction?

Disposable Pre-calibrated Suction is manufactured by Brainlab AG.

What is the FDA product code for Disposable Pre-calibrated Suction?

The FDA product code for Disposable Pre-calibrated Suction is HAW.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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