510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971455Substantially Equivalent

Clarus Model 5197 Sightlite

Clarus Medical Systems, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971455 is the FDA 510(k) clearance record for CLARUS MODEL 5197 SIGHTLITE, a class II device, cleared for Clarus Medical Systems, Inc. on under FDA product code FTI (Lamp, Endoscope, Incandescent). FDA records list 22 510(k) clearances for Clarus Medical Systems, Inc., from to . As of , FDA records show no recalls naming K971455.

Clearance record

Decision date
Received
(29 days to decision)
Product code
FTI Lamp, Endoscope, Incandescent
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Clarus Medical Systems, Inc. 1000 Boone Ave. N., Minneapolis MN
510(k) summary
Summary
Third party review
No

Clearances, product code FTI

Trailing 12 months

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

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