510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K772134Substantially Equivalent

Syringe, Irrigation, Pre-Filled

Kendall Research Center, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K772134 is the FDA 510(k) clearance record for SYRINGE, IRRIGATION, PRE-FILLED, a class I device, cleared for Kendall Research Center on under FDA product code KOA (Surgical Instruments, G-U, Manual (And Accessories)). FDA records list 14 510(k) clearances for Kendall Research Center, from to . As of , FDA records show no recalls naming K772134.

Clearance record

Decision date
Received
(14 days to decision)
Product code
KOA Surgical Instruments, G-U, Manual (And Accessories)
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Kendall Research Center 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KOA

Trailing 12 months

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

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