Decision Date1995-08-23
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
UIMAT PUMP 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 1995-08-23 under 510(k) number K953132. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the UIMAT PUMP?
UIMAT PUMP is a medical device that received FDA 510(k) clearance on 1995-08-23. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K953132.
When did UIMAT PUMP receive FDA 510(k) clearance?
UIMAT PUMP received FDA 510(k) clearance on 1995-08-23, under 510(k) number K953132.
Who is the listed applicant for UIMAT PUMP?
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 UIMAT PUMP?
The FDA product code for UIMAT PUMP is BTA.
Related Clinical Trials
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Other records listing KARL STORZ Endoscopy-America, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.