Ksea Calcuson

FDA 510(k) K973251 · KARL STORZ Endoscopy-America, Inc.

Substantially Equivalent

510(k) numberK973251

Submission

Device name
Ksea Calcuson
Applicant
KARL STORZ Endoscopy-America, Inc.
Culver City, CA, US
Received
August 29, 1997
Decision date
June 22, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FEO – Lithotriptor, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4480
Specialty
Gastroenterology, Urology

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Questions and answers

When was Ksea Calcuson cleared by the FDA?

Ksea Calcuson (K973251) received a 510(k) decision of Substantially Equivalent on June 22, 1998, 297 days after the submission was received.

What is the product code of K973251?

The FDA product code is FEO – Lithotriptor, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 876.4480.