Owens Endoscopic Instruments and Accessories

FDA 510(k) K926596 · Owens Industries, Inc.

Substantially Equivalent

510(k) numberK926596

Submission

Device name
Owens Endoscopic Instruments and Accessories
Applicant
Owens Industries, Inc.
Oak Creek, WI, US
Received
September 9, 1992
Decision date
June 10, 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.

510(k)DeviceDecision
K926594Owens Laparoscopy Instruments and AccessoriesHET · Traditional 06/06/1994SE
K926595Owens Biopsy ForcepsHFB · Traditional 05/25/1994SE
K932796Owens TrocarGCJ · Traditional 02/02/1994SE

Questions and answers

When was Owens Endoscopic Instruments and Accessories cleared by the FDA?

Owens Endoscopic Instruments and Accessories (K926596) received a 510(k) decision of Substantially Equivalent on June 10, 1994, 639 days after the submission was received.

What is the product code of K926596?

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