Laparoscope, Gynecologic (and Accessories)

FDA 510(k) K926597 · Optimed Technologies, Inc.

Substantially Equivalent

510(k) numberK926597

Submission

Device name
Laparoscope, Gynecologic (and Accessories)
Applicant
Optimed Technologies, Inc.
Orange, CA, US
Received
April 24, 1992
Decision date
July 12, 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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More from 270surgical , Ltd.

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K972520OptiviewLLZ · Traditional 09/29/1997SE
K955276Booster Lite 4 Motorized ScooterINI · Traditional 11/04/1996SE
K955275Booster Trophy 5 Motorized ScooterINI · Traditional 11/04/1996SE
K955274Booster Lite 3 Motorized ScooterINI · Traditional 11/04/1996SE
K943598Flexible Fiber Optic LaparoscopesHET · Traditional 10/18/1994SE
K921942Hysteroscope (and Accessories)HIH · Traditional 06/24/1994SE
K922711Flexible Fiber Optic Gynecologic EndoscopeHIH · Traditional 05/17/1994SE
K921985Arthroscope & AccessoriesHRX · Traditional 06/29/1993SE
K922826Flexible Fiber Optic EndoscopeFGA · Traditional 02/19/1993SE
K921883EndoscopeGCM · Traditional 11/23/1992SE

Questions and answers

When was Laparoscope, Gynecologic (and Accessories) cleared by the FDA?

Laparoscope, Gynecologic (and Accessories) (K926597) received a 510(k) decision of Substantially Equivalent on July 12, 1994, 809 days after the submission was received.

What is the product code of K926597?

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