510(k) Report

Devices descending from DEN130015

5 later devices reach Pixel 3 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160338Triton SystemGauss Surgical, Inc.,20163—
+1K142801Triton Canister SystemGauss Surgical, Inc.,201504
+2K163507Triton Sponge SystemGauss Surgical, Inc.,20172—
+3K232250SurgiCount+ SystemStryker Instruments20241—
+4K252282SurgiCount+ SystemStryker Instruments20260—