Safety Trocer with Springloaded Obdurator

FDA 510(k) K960347 · Spiess Design, Inc.

Substantially Equivalent

510(k) numberK960347

Submission

Device name
Safety Trocer with Springloaded Obdurator
Applicant
Spiess Design, Inc.
Lake Zurich, IL, US
Received
January 25, 1996
Decision date
July 1, 1996
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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Questions and answers

When was Safety Trocer with Springloaded Obdurator cleared by the FDA?

Safety Trocer with Springloaded Obdurator (K960347) received a 510(k) decision of Substantially Equivalent on July 1, 1996, 158 days after the submission was received.

What is the product code of K960347?

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