MaxTack Motorized Fixation Device
FDA 510(k) K231240 · Covidien
510(k) numberK231240
Submission
- Device name
- MaxTack Motorized Fixation Device
- Applicant
- Covidien
North Haven, CT, US - Received
- April 28, 2023
- Decision date
- September 8, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCW – Endoscopic Tissue Approximation Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
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Questions and answers
When was MaxTack Motorized Fixation Device cleared by the FDA?
MaxTack Motorized Fixation Device (K231240) received a 510(k) decision of Substantially Equivalent on September 8, 2023, 133 days after the submission was received.
What is the product code of K231240?
The FDA product code is OCW – Endoscopic Tissue Approximation Device, a Class II (moderate risk) device regulated under 21 CFR 876.1500.