Stryker Endoscopy - FDA 510(k) Cleared Devices
Recent clearances: AIR+ All-Inside Meniscal Repair Device, Curved Up, Precision S 4K Sinuscope, 780 nm SPY Portable Handheld Imaging (SPY-PHI) System
103
Total
102
Cleared
1
Denied
FDA 510(k) Regulatory Record - Stryker Endoscopy General & Plastic Surgery ✕
41 devices
Cleared
May 28, 2026
780 nm SPY Portable Handheld Imaging (SPY-PHI) System
General & Plastic Surgery
59d
Cleared
Feb 18, 2026
1688 4K Camera System with Advanced Imaging Modality
General & Plastic Surgery
28d
Cleared
Feb 12, 2026
L12 LED Light Source with AIM
General & Plastic Surgery
29d
Cleared
Jan 13, 2026
Connected OR Hub with Device and Voice Control
General & Plastic Surgery
29d
Cleared
Dec 31, 2025
MOLLI 2 System
General & Plastic Surgery
27d
Cleared
Jul 24, 2025
SPY Laparoscope
General & Plastic Surgery
27d
Cleared
Aug 15, 2024
Connected OR Hub with Device and Voice Control
General & Plastic Surgery
90d
Cleared
Feb 22, 2024
1688 4K Camera System with Advanced Imaging Modality
General & Plastic Surgery
30d
Cleared
Jan 09, 2024
1788 4K Camera System with Advanced Imaging Modality
General & Plastic Surgery
102d
Cleared
Jun 21, 2023
Connected OR Hub with Device and Voice Control
General & Plastic Surgery
82d
Cleared
Oct 11, 2022
Connected OR Hub with Device and Voice Control, SDC4K Information Management...
General & Plastic Surgery
88d
Cleared
Feb 09, 2022
SDC4K Information Management System with Device and Voice Control Package
General & Plastic Surgery
27d
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