Karl Storz Semi-Rigid Micro-Endoscopes and Accessories for Adult and Pediatric Endoscopic Urology Procedures

FDA 510(k) K945907 · KARL STORZ Endoscopy-America, Inc.

Substantially Equivalent

510(k) numberK945907

Submission

Device name
Karl Storz Semi-Rigid Micro-Endoscopes and Accessories for Adult and Pediatric Endoscopic Urology Procedures
Applicant
KARL STORZ Endoscopy-America, Inc.
Culver City, CA, US
Received
December 2, 1994
Decision date
May 12, 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
FGC – Urethroscope
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

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Questions and answers

When was Karl Storz Semi-Rigid Micro-Endoscopes and Accessories for Adult and Pediatric Endoscopic Urology Procedures cleared by the FDA?

Karl Storz Semi-Rigid Micro-Endoscopes and Accessories for Adult and Pediatric Endoscopic Urology Procedures (K945907) received a 510(k) decision of Substantially Equivalent on May 12, 1995, 161 days after the submission was received.

What is the product code of K945907?

The FDA product code is FGC – Urethroscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.