510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K892218Substantially Equivalent

Endo-Sponge

Endovations, Mechanicsburg PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892218 is the FDA 510(k) clearance record for ENDO-SPONGE, a class I device, cleared for Endovations on under FDA product code MNL (Accessories, Cleaning Brushes, For Endoscope). FDA records list 38 510(k) clearances for Endovations, from to . As of , FDA records show no recalls naming K892218.

Clearance record

Decision date
Received
(58 days to decision)
Product code
MNL Accessories, Cleaning Brushes, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Endovations Rossmoyne Industrial Park, Mechanicsburg PA
Third party review
No

Clearances, product code MNL

Trailing 12 months

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

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