
Stryker Endoscopy
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780 nm SPY Portable Handheld Imaging (SPY-PHI) System is an FDA 510(k)-cleared medical device (K261037) manufactured by Stryker Endoscopy. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 27, 2026. Regulation: 8.

ADC
SKU DX606933

MDF
SKU DX683863

3M Littmann
SKU DX771242

Welch Allyn
SKU DX297280