510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061622Substantially Equivalent

Ps Series

Photonic Optische Gerate Gesmbh & Cokg, Vienna, AT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061622 is the FDA 510(k) clearance record for PS SERIES, a class II device, cleared for Photonic Optische Gerate Gesmbh & Cokg on under FDA product code FFS (Image, Illumination, Fiberoptic, For Endoscope). FDA records list one 510(k) clearance for Photonic Optische Gerate Gesmbh & Cokg. As of , FDA records show no recalls naming K061622.

Clearance record

Decision date
Received
(266 days to decision)
Product code
FFS Image, Illumination, Fiberoptic, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Photonic Optische Gerate Gesmbh & Cokg Seebockgasse 59, Vienna, AT
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code FFS

Trailing 12 months

FDA records hold no clearances under product code FFS in the trailing twelve months.

FDA records show no clearances under product code FFS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FFS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260