Decision Date1995-09-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
TAKE-APART SCISSORS 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 1995-09-14 under 510(k) number K954122. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TAKE-APART SCISSORS?
TAKE-APART SCISSORS is a medical device that received FDA 510(k) clearance on 1995-09-14. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K954122.
When did TAKE-APART SCISSORS receive FDA 510(k) clearance?
TAKE-APART SCISSORS received FDA 510(k) clearance on 1995-09-14, under 510(k) number K954122.
Who is the listed applicant for TAKE-APART SCISSORS?
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 TAKE-APART SCISSORS?
The FDA product code for TAKE-APART SCISSORS is GEI.
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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.