Stryker Endoscopy

FDA Regulatory Profile

Summary

Total Recalls
238
510(k) Clearances
101
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1566-2016Class IIPneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPMarch 28, 2016
Z-1831-2015Class IISERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for arJune 3, 2015
Z-0727-2015Class IIPKG, 5MM INSERT, ENDO GRASPER, 33CM, P/N 0250080699 Laparoscopic Manual Instruments are intended foNovember 17, 2014
Z-0796-2015Class IIPKG, 3MM X 29CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250282105 Laparoscopic Manual InstrumNovember 17, 2014
Z-0721-2015Class IIPKG, 10MM PEEK MONOPOLAR HANDLE, P/N 0250080618 Laparoscopic Manual Instruments are intended for cuNovember 17, 2014
Z-0659-2015Class IIPKG, BIOPSY FORCEPS, PUNCH, P/N 0250080290. Laparoscopic Manual Instruments are intended for cuttiNovember 17, 2014
Z-0595-2015Class IIPKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 Laparoscopic Manual Instruments are intended November 17, 2014
Z-0667-2015Class IIPKG, BIPOLAR FORCEPS, FENESTRATED 45CM, P/N 0250080113. Laparoscopic Manual Instruments are intendeNovember 17, 2014
Z-0787-2015Class IIPKG, 3MM INSERT, BIOPSY PUNCH, 29CM, P/N 0250282060 Laparoscopic Manual Instruments are intended foNovember 17, 2014
Z-0600-2015Class IIPKG, MYOMA DRILL 5MM LENGTH 320MM, P/N 0250080133 Laparoscopic Manual Instruments are intended for November 17, 2014
Z-0782-2015Class IIPKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 29CM, P/N 0250282055 Laparoscopic Manual Instruments arNovember 17, 2014
Z-0766-2015Class IIPKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 20CM, P/N 0250282008 Laparoscopic Manual Instruments arNovember 17, 2014
Z-0597-2015Class IIPKG, OP-BIOPSY FORCEPS, SPOON JAW, P/N 0250080007 Laparoscopic Manual Instruments are intended for November 17, 2014
Z-0770-2015Class IIPKG, 3MM INSERT, BIOPSY FORCEPS, 20CM, P/N 0250282012 Laparoscopic Manual Instruments are intended November 17, 2014
Z-0649-2015Class IIPKG, MICRO SCISSORS, CURVED, P/N 0250080270. Laparoscopic Manual Instruments are intended for cuttNovember 17, 2014
Z-0741-2015Class IIPKG, 5MM INSERT, 45CM, PARK FORCEPS, P/N 0250080745 Laparoscopic Manual Instruments are intended foNovember 17, 2014
Z-0788-2015Class IIPKG, 3MM INSERT, STRAIGHT NEEDLEHOLDER, 29CM, P/N 0250282061 Laparoscopic Manual Instruments are inNovember 17, 2014
Z-0662-2015Class IIPKG, TROCAR, 8MM, PYRAMIDAL TIP, P/N 0250080155. Laparoscopic Manual Instruments are intended foNovember 17, 2014
Z-0653-2015Class IIPKG, KELLY FORCEPS, CURVED LEFT, P/N 0250080283. Laparoscopic Manual Instruments are intended for November 17, 2014
Z-0710-2015Class IIPKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, DOUBLE ACTION 45CM, P/N 0250080585 Laparoscopic ManualNovember 17, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K253602Precision S 4K SinuscopeJune 4, 2026
K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemMay 28, 2026
K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging MoFebruary 18, 2026
K260108L12 LED Light Source with AIMFebruary 12, 2026
K254014Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and January 13, 2026
K253888MOLLI 2 SystemDecember 31, 2025
K252010SPY LaparoscopeJuly 24, 2025
K252012SPY Cystoscope/HysteroscopeJuly 18, 2025
K250544Knotilus+ Biocomposite Knotless AnchorMay 23, 2025
K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorMay 21, 2025
K241401Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and August 15, 2024
K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture AnchorMarch 7, 2024
K2401741688 4K Camera System with Advanced Imaging ModalityFebruary 22, 2024
K233635SPY Cystoscope/HysteroscopeFebruary 12, 2024
K233893AlphaVent Knotless SP PEEK AnchorJanuary 25, 2024
K2333271788 4K Camera System with Advanced Imaging ModalityJanuary 9, 2024
K232683Knotilus+ PEEK Knotless AnchorOctober 24, 2023
K231093AlphaVent Suture AnchorsAugust 30, 2023
K230886Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and June 21, 2023
K222079Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and October 11, 2022