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Bmc Rf Cannula

by Baylis Medical Co., Inc.

510(k) K972846

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972846 Date17 Jul 1998ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0850-2014 FDA Class II initiated 29 Oct 2013

    Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.

    • Terminated Z-0879-2013 FDA Class II initiated 4 Oct 2012

    A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. Thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. The cannulas were not used on any patients, as the unsealed packages

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GXI
Device Class
Class II
Regulation
21 CFR Part 882.4725
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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