Karl Storz Take-Apart Rotating Grasping Forceps

FDA 510(k) K952149 · KARL STORZ Endoscopy-America, Inc.

Substantially Equivalent

510(k) numberK952149

Submission

Device name
Karl Storz Take-Apart Rotating Grasping Forceps
Applicant
KARL STORZ Endoscopy-America, Inc.
Culver City, CA, US
Received
May 8, 1995
Decision date
June 15, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LQR – Dislodger, Stone, Biliary
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5010
Specialty
Gastroenterology, Urology

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Questions and answers

When was Karl Storz Take-Apart Rotating Grasping Forceps cleared by the FDA?

Karl Storz Take-Apart Rotating Grasping Forceps (K952149) received a 510(k) decision of Substantially Equivalent on June 15, 1995, 38 days after the submission was received.

What is the product code of K952149?

The FDA product code is LQR – Dislodger, Stone, Biliary, a Class II (moderate risk) device regulated under 21 CFR 876.5010.