510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K931153Substantially Equivalent

Elper(tm) Barrier Integrity Monitoring

Igea, S.r.l., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931153 is the FDA 510(k) clearance record for ELPER(TM) BARRIER INTEGRITY MONITORING, cleared for Igea, S.R.L. on under FDA product code LDQ. FDA records list one 510(k) clearance for Igea, S.R.L. As of , FDA records show no recalls naming K931153.

Clearance record

Decision date
Received
(254 days to decision)
Product code
LDQ
Review panel
General Hospital
Applicant
Igea, S.R.L. C/O Hogan & Hartson, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code LDQ

Trailing 12 months

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

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