Laparoview
FDA 510(k) K931065 · Northgate Technologies, Inc.
510(k) numberK931065
Submission
- Device name
- Laparoview
- Applicant
- Northgate Technologies, Inc.
Arlington Heights, IL, US - Received
- March 1, 1993
- Decision date
- November 30, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Laparoview cleared by the FDA?
Laparoview (K931065) received a 510(k) decision of Substantially Equivalent on November 30, 1994, 639 days after the submission was received.
What is the product code of K931065?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.