Surgetics Entact Endonasal Navigation System

FDA 510(k) K022239 · Praxim

Substantially Equivalent

510(k) numberK022239

Submission

Device name
Surgetics Entact Endonasal Navigation System
Applicant
Praxim
North Attleboro, MA, US
Received
July 11, 2002
Decision date
August 23, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAK – System, X-Ray, Tomography, Computed
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1750
Specialty
Radiology

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Questions and answers

When was Surgetics Entact Endonasal Navigation System cleared by the FDA?

Surgetics Entact Endonasal Navigation System (K022239) received a 510(k) decision of Substantially Equivalent on August 23, 2002, 43 days after the submission was received.

What is the product code of K022239?

The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.