Nephromax High Pressure Nephrostomy Baloon Dilatation Catheter

510(k) K121614

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

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	NumberK121614	Date18 Sep 2012Cleared	StatusActive

3 recalls · 1 ongoing · FDA

- Ongoing Z-2535-2025 FDA Class II initiated 5 Aug 2025
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
2 recalls, same reason
- Terminated Z-1673-2013 FDA Class II initiated 28 May 2013
- Terminated Z-1672-2013 FDA Class II initiated 28 May 2013
Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

1 jurisdiction

United States — FDA 510(k) Active

510(k)