CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT - C

510(k) K102875

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 closed

Documents

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK102875	Date20 Dec 2010Cleared	StatusActive

3 recalls · FDA

- Terminated Z-1815-2015 FDA Class II initiated 27 May 2015
Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Catheters because they may have been incorrectly assembled. Specifically, the o-ring in the bolt adapter may be in the wrong location and as a result, there is a potential CSF/blood could leak from the bolt adapter.
- Terminated Z-2072-2014 FDA Class II initiated 9 Jul 2014 on shared 510(k) K102875
Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.
- Terminated Z-0117-2014 FDA Class II initiated 10 Sep 2013
Integra LifeSciences has identified through an internal evaluation that in order to comply with US FDA requirements, certain Camino Intracranial Pressure Monitoring Kits require additional labelling to indicate they are UNSAFE in an MR environment. Only the following Camino Intracranial Pressure Monitoring Kits are affected: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)

510(k) Number: K102875
FDA Product Code: GWM
Models / Variants: Camino 110-4B Olm Intracranial Pressure Mnitoring Kit
Camino 110-4g Post Craniotomy Subdural Pressure Monitoring Kit
C