510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151308Substantially Equivalent

Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set

Schoelly Fiberoptic, GmbH, Denzlingen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151308 is the FDA 510(k) clearance record for Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set, a class II device, cleared for Schoelly Fiberoptic GmbH on under FDA product code FGA (Kit, Nephroscope). FDA records list 15 510(k) clearances for Schoelly Fiberoptic GmbH, from to . As of , FDA records show no recalls naming K151308.

Clearance record

Decision date
Received
(267 days to decision)
Product code
FGA Kit, Nephroscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Schoelly Fiberoptic GmbH Robert-Bosch-Str. 1-3, Denzlingen, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FGA

Trailing 12 months

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

FDA records show no clearances under product code FGA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FGA, 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