Hysteromed 100
FDA 510(k) K930912 · Northgate Technologies, Inc.
510(k) numberK930912
Submission
- Device name
- Hysteromed 100
- Applicant
- Northgate Technologies, Inc.
Arlington Heights, IL, US - Received
- February 22, 1993
- Decision date
- October 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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Questions and answers
When was Hysteromed 100 cleared by the FDA?
Hysteromed 100 (K930912) received a 510(k) decision of Substantially Equivalent on October 17, 1994, 602 days after the submission was received.
What is the product code of K930912?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.