510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840004Substantially Equivalent

Wee Bag O'mercury

Surgi-Quip Inc.U, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840004 is the FDA 510(k) clearance record for WEE BAG O'MERCURY, a class II device, cleared for Surgi-Quip Inc.U on under FDA product code LCC (Applicator, Ocular Pressure). FDA records list 8 510(k) clearances for Surgi-Quip Inc.U, from to . As of , FDA records show no recalls naming K840004.

Clearance record

Decision date
Received
(78 days to decision)
Product code
LCC Applicator, Ocular Pressure
Regulation
21 CFR 886.4610
Device class
Class II
Review panel
Ophthalmic
Applicant
Surgi-Quip Inc.U 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LCC

Trailing 12 months

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

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