FDA 510(k) K241169, Entarik NI Feeding Tube System, by Gravitas Medical, Inc.

FDA 510(k) K241169, Entarik NI Feeding Tube System, by Gravitas Medical, Inc.

Regular price $1,258.49 USD
Regular price Sale price $1,258.49 USD
Sale Sold out

Device Classification Name: Tubes, Gastrointestinal (And Accessories)
510(k) Number: K241169
Device Name: Entarik NI Feeding Tube System
Applicant: Gravitas Medical, Inc.
Regulation Number: 876.5980
Classification Product Code: KNT
Date Received: 04/26/2024
Decision Date: 11/22/2024
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: Gastroenterology/Urology

Total number of pages: 2,286
Fully redacted pages: 1,803
Content pages: 483

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.

View full details