Stryker Endoscopy

FDA Regulatory Profile

Summary

Total Recalls
238
510(k) Clearances
99
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-0642-2015Class IIPKG, METZENBAUM SCISSORS, STRAIGHT, LONG, P/N 0250080263. Laparoscopic Manual Instruments are inteNovember 17, 2014
Z-0710-2015Class IIPKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, DOUBLE ACTION 45CM, P/N 0250080585 Laparoscopic ManualNovember 17, 2014
Z-0790-2015Class IIPKG, 3MM INSERT, DORSEY GRASPER, 29CM, P/N 0250282097 Laparoscopic Manual Instruments are intended November 17, 2014
Z-0770-2015Class IIPKG, 3MM INSERT, BIOPSY FORCEPS, 20CM, P/N 0250282012 Laparoscopic Manual Instruments are intended November 17, 2014
Z-0632-2015Class IIPKG, CLAW FORCEPS, P/N 0250080244. Laparoscopic Manual Instruments are intended for cutting, holdiNovember 17, 2014
Z-0787-2015Class IIPKG, 3MM INSERT, BIOPSY PUNCH, 29CM, P/N 0250282060 Laparoscopic Manual Instruments are intended foNovember 17, 2014
Z-0761-2015Class IIPKG, 3MM INSERT, FUNDUS GRASPER, 20CM, P/N 0250282003 Laparoscopic Manual Instruments are intended November 17, 2014
Z-0727-2015Class IIPKG, 5MM INSERT, ENDO GRASPER, 33CM, P/N 0250080699 Laparoscopic Manual Instruments are intended foNovember 17, 2014
Z-0705-2015Class IIPKG,5MM 45CM INSERT,PERFORATOR, P/N 0250080578S1 Laparoscopic Manual Instruments are intended for cNovember 17, 2014
Z-0653-2015Class IIPKG, KELLY FORCEPS, CURVED LEFT, P/N 0250080283. Laparoscopic Manual Instruments are intended for November 17, 2014
Z-0618-2015Class IIPKG, LUERLOCK, MALE, 6MM TUBING, P/N 0250080207. Laparoscopic Manual Instruments are intended for November 17, 2014
Z-0619-2015Class IIPKG, LUERLOCK, FEMALE, 6MM TUBING, P/N 0250080208. Laparoscopic Manual Instruments are intended foNovember 17, 2014
Z-0659-2015Class IIPKG, BIOPSY FORCEPS, PUNCH, P/N 0250080290. Laparoscopic Manual Instruments are intended for cuttiNovember 17, 2014
Z-0777-2015Class IIPKG, 3MM INSERT, HOOK SCISSORS, 29CM, P/N 0250282049 Laparoscopic Manual Instruments are intended fNovember 17, 2014
Z-0595-2015Class IIPKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 Laparoscopic Manual Instruments are intended November 17, 2014
Z-0782-2015Class IIPKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 29CM, P/N 0250282055 Laparoscopic Manual Instruments arNovember 17, 2014
Z-0741-2015Class IIPKG, 5MM INSERT, 45CM, PARK FORCEPS, P/N 0250080745 Laparoscopic Manual Instruments are intended foNovember 17, 2014
Z-0649-2015Class IIPKG, MICRO SCISSORS, CURVED, P/N 0250080270. Laparoscopic Manual Instruments are intended for cuttNovember 17, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
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
K220108SDC4K Information Management System with Device and Voice Control PackageFebruary 9, 2022
K211502Alpha Vent PEEK Suture AnchorAugust 4, 2021