Decision Date1994-06-27
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 1994-06-27 under 510(k) number K941779. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE?
KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE is a medical device that received FDA 510(k) clearance on 1994-06-27. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K941779.
When did KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE receive FDA 510(k) clearance?
KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE received FDA 510(k) clearance on 1994-06-27, under 510(k) number K941779.
Who is the listed applicant for KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE?
The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE?
The FDA product code for KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE is FAJ.
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Other records listing KARL STORZ Endoscopy-America, Inc. as applicant
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.