510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091968Substantially Equivalent

Karl Storz LED Nova 100 Cold Light Fountain, Models 2016020, 20161020C

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

K091968 is the FDA 510(k) clearance record for KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C, a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code FCW (Light Source, Fiberoptic, Routine). FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show no recalls naming K091968.

Clearance record

Decision date
Received
(75 days to decision)
Product code
FCW Light Source, Fiberoptic, Routine
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
Statement
Third party review
No

Clearances, product code FCW

Trailing 12 months

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

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