Tri Talon Retrieval Forceps

FDA 510(k) K973071 · Medical Engineering Laboratory, Inc.

Substantially Equivalent

510(k) numberK973071

Submission

Device name
Tri Talon Retrieval Forceps
Applicant
Medical Engineering Laboratory, Inc.
Shelby, NC, US
Received
August 18, 1997
Decision date
October 24, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.

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Questions and answers

When was Tri Talon Retrieval Forceps cleared by the FDA?

Tri Talon Retrieval Forceps (K973071) received a 510(k) decision of Substantially Equivalent on October 24, 1997, 67 days after the submission was received.

What is the product code of K973071?

The FDA product code is OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered, a Class II (moderate risk) device regulated under 21 CFR 876.1500.