510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K141781Substantially Equivalent

Kogent Spetzler Lighted Suction Tubes

Katalyst Surgical, LLC, Chesterfield MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141781 is the FDA 510(k) clearance record for KOGENT SPETZLER LIGHTED SUCTION TUBES, a class II device, cleared for Katalyst Surgical, LLC on under FDA product code HBI (Illuminator, Fiberoptic, Surgical Field). FDA records list 7 510(k) clearances for Katalyst Surgical, LLC, from to . As of , FDA records show no recalls naming K141781.

Clearance record

Decision date
Received
(281 days to decision)
Product code
HBI Illuminator, Fiberoptic, Surgical Field
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Katalyst Surgical, LLC 754 Goddard Ave., Chesterfield MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HBI

Trailing 12 months

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

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