Fujitsu Malleable - Tip Brain Spatula

FDA 510(k) K862331 · Downs Surgical , Ltd.

Substantially Equivalent

510(k) numberK862331

Submission

Device name
Fujitsu Malleable - Tip Brain Spatula
Applicant
Downs Surgical , Ltd.
Wilmington, MA, US
Received
June 19, 1986
Decision date
July 1, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HAO – Instrument, Surgical, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 882.4535
Specialty
Neurology

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Questions and answers

When was Fujitsu Malleable - Tip Brain Spatula cleared by the FDA?

Fujitsu Malleable - Tip Brain Spatula (K862331) received a 510(k) decision of Substantially Equivalent on July 1, 1986, 12 days after the submission was received.

What is the product code of K862331?

The FDA product code is HAO – Instrument, Surgical, Non-Powered, a Class I (low risk) device regulated under 21 CFR 882.4535.