Hysteromat Hysteroflator Hysteroscopic Insufflator

FDA 510(k) K905495 · Frigitronics, Inc.

Substantially Equivalent

510(k) numberK905495

Submission

Device name
Hysteromat Hysteroflator Hysteroscopic Insufflator
Applicant
Frigitronics, Inc.
Mountain View, CA, US
Received
December 7, 1990
Decision date
April 29, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HIG – Insufflator, Hysteroscopic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1700
Specialty
Obstetrics/Gynecology

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More from Thermedx, LLC

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Questions and answers

When was Hysteromat Hysteroflator Hysteroscopic Insufflator cleared by the FDA?

Hysteromat Hysteroflator Hysteroscopic Insufflator (K905495) received a 510(k) decision of Substantially Equivalent on April 29, 1991, 143 days after the submission was received.

What is the product code of K905495?

The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.