510(k) clearance
OnControl Powered Bone Access Systems;OnControl Bone Marrow Aspiration System;OnControl Bone Marrow Biopsy System;OnControl Bone Lesion Biopsy System;OnControl Power Driver
- 510(k) number
- K262531
- Applicant
- Teleflex Medical, LLC
- Decision date
- Oct 27, 2026
- Date received
- Jul 22, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- KNW
- Device type
- Instrument, Biopsy
- Device class
- Class II
- Regulation
- 21 CFR 876.1075
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Morrisville, NC, US