510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921464Substantially Equivalent

Cat.#40100, 40102, 40104 & 40106 Yankauer Suct Int

Trinity Laboratories, Inc., Salisbury MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921464 is the FDA 510(k) clearance record for CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT, a class I device, cleared for Trinity Laboratories, Inc. on under FDA product code GBQ (Catheter, Continuous Irrigation). FDA records list 44 510(k) clearances for Trinity Laboratories, Inc., from to . As of , FDA records show no recalls naming K921464.

Clearance record

Decision date
Received
(39 days to decision)
Product code
GBQ Catheter, Continuous Irrigation
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Trinity Laboratories, Inc. 201 Kiley Dr., Salisbury MD
510(k) summary
Statement
Third party review
No

Clearances, product code GBQ

Trailing 12 months

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

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