510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895757Substantially Equivalent

Irri-Evacuator

Mikro-Tek Laboratories, Bloomington IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895757 is the FDA 510(k) clearance record for IRRI-EVACUATOR, a class I device, cleared for Mikro-Tek Laboratories on under FDA product code GBX (Catheter, Irrigation). FDA records list 3 510(k) clearances for Mikro-Tek Laboratories, from to . As of , FDA records show no recalls naming K895757.

Clearance record

Decision date
Received
(23 days to decision)
Product code
GBX Catheter, Irrigation
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Mikro-Tek Laboratories 220 S. Lori Ln., Bloomington IN
Third party review
No

Clearances, product code GBX

Trailing 12 months

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

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