510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261037Substantially Equivalent

780 nm SPY Portable Handheld Imaging (SPY-PHI) System

Stryker Corp., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K261037 is the FDA 510(k) clearance record for 780 nm SPY Portable Handheld Imaging (SPY-PHI) System, a class II device, cleared for Stryker Endoscopy on under FDA product code IZI (System, X-Ray, Angiographic). FDA records list 568 510(k) clearances for STRYKER CORP., from to . As of , FDA records show no recalls naming K261037.

Clearance record

Decision date
Received
(59 days to decision)
Product code
IZI System, X-Ray, Angiographic
Regulation
21 CFR 892.1600
Device class
Class II
Review panel
Radiology
Applicant
Stryker Endoscopy 5900 Optical Ct., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IZI

Trailing 12 months
2 clearances under product code IZI in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IZI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20262
June 20260
July 20260
August 20260
September 20260
October 20260