510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K962212Substantially Equivalent

Karl Storz Frimberger Varioguide

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

K962212 is the FDA 510(k) clearance record for KARL STORZ FRIMBERGER VARIOGUIDE, a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code FDT (Duodenoscope And Accessories, Flexible/Rigid). FDA's definition for product code FDT reads: "To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82...". FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show no recalls naming K962212.

Clearance record

Decision date
Received
(186 days to decision)
Product code
FDT Duodenoscope And Accessories, Flexible/Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
KARL STORZ Endoscopy-America, Inc. 600 Corporate Pt.e, Culver City CA
510(k) summary
Summary
Third party review
No

Clearances, product code FDT

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