510(k) K193438

DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) by Pro Med Instruments GmbH — Product Code HBL

K193438 is an FDA 510(k) premarket notification submitted by Pro Med Instruments GmbH for the device "DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)". The FDA issued a decision of Substantially Equivalent on June 2, 2020. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. Pro Med Instruments GmbH has at least 5 other 510(k) clearances on record.