510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091992Substantially Equivalent

Eidosmed, Model Edg4.0

Eidosmed, LLC, Deerfield IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091992 is the FDA 510(k) clearance record for EIDOSMED, MODEL EDG4.0, a class II device, cleared for Eidosmed, LLC on under FDA product code OOL (Electronic Depth Gauge). FDA's definition for product code OOL reads: "For measuring the depth of a passageway in bone or tissue, prior to insertion of screws or other hardware. The device is an electronic depth gauge for various medical purposes including, measuring the depth of a passageway in a bone or...". FDA records list one 510(k) clearance for Eidosmed, LLC. As of , FDA records show no recalls naming K091992.

Clearance record

Decision date
Received
(160 days to decision)
Product code
OOL Electronic Depth Gauge
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Eidosmed, LLC 333 Milford Rd., Deerfield IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OOL

Trailing 12 months

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

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