FDA 510(k) K240776, Celsio Flexible Cryocatheter System, by Endocision Technologies, Inc.

FDA 510(k) K240776, Celsio Flexible Cryocatheter System, by Endocision Technologies, Inc.

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Device Classification Name: Unit, Cryosurgical, Accessories
510(k) Number: K240776
Device Name: Celsio Flexible Cryocatheter System
Applicant: Endocision Technologies, Inc.
Regulation Number: 878.4350
Classification Product Code: GEH
Date Received: 03/21/2024
Decision Date: 09/24/2024
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
510k Review Panel: General & Plastic Surgery

Total number of pages: 1,445
Fully redacted pages: 985
Content pages: 460

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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