510(k) K963648

STRYKER SUCTION REGULATOR by Stryker Endoscopy — Product Code GCX

K963648 is an FDA 510(k) premarket notification submitted by Stryker Endoscopy for the device "STRYKER SUCTION REGULATOR". The FDA issued a decision of Substantially Equivalent on November 26, 1996. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Stryker Endoscopy has at least 10 other 510(k) clearances on record.