Flexible Fiber Optic Laparoscopes

FDA 510(k) K943598 · Optimed Technologies, Inc.

Substantially Equivalent

510(k) numberK943598

Submission

Device name
Flexible Fiber Optic Laparoscopes
Applicant
Optimed Technologies, Inc.
Orange, CA, US
Received
July 26, 1994
Decision date
October 18, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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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K926597Laparoscope, Gynecologic (and Accessories)HET · Traditional 07/12/1994SE
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Questions and answers

When was Flexible Fiber Optic Laparoscopes cleared by the FDA?

Flexible Fiber Optic Laparoscopes (K943598) received a 510(k) decision of Substantially Equivalent on October 18, 1994, 84 days after the submission was received.

What is the product code of K943598?

The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.