Fisch Drill Irrigator

FDA 510(k) K861298 · Jedmed Instrument Co.

Substantially Equivalent

510(k) numberK861298

Submission

Device name
Fisch Drill Irrigator
Applicant
Jedmed Instrument Co.
St. Louis, MO, US
Received
April 7, 1986
Decision date
April 23, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KAR – Irrigator, Sinus
Device class
Class I (low risk)
Regulation
21 CFR 874.4420
Specialty
Ear, Nose, Throat

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Questions and answers

When was Fisch Drill Irrigator cleared by the FDA?

Fisch Drill Irrigator (K861298) received a 510(k) decision of Substantially Equivalent on April 23, 1986, 16 days after the submission was received.

What is the product code of K861298?

The FDA product code is KAR – Irrigator, Sinus, a Class I (low risk) device regulated under 21 CFR 874.4420.