510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160044Substantially Equivalent

Image1 SPIES System

Karl Storz Endoscopy-America, Inc., El Segundo CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160044 is the FDA 510(k) clearance record for Image1 SPIES System, a class II device, cleared for Karl Storz Endoscopy America, Inc. on under FDA product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology). FDA's definition for product code FET reads: "To allow for visualization of body cavities through an endoscope by projecting images to a monitor". FDA records list 402 510(k) clearances for Karl Storz Endoscopy America, Inc., from to . As of , FDA records show no recalls naming K160044.

Clearance record

Decision date
Received
(24 days to decision)
Product code
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Karl Storz Endoscopy America, Inc. 2151 E. Grand Ave., El Segundo CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FET

Trailing 12 months
3 clearances under product code FET in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FET, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20261
October 20260