510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153698Substantially Equivalent

LumenR Tissue Retractor System

Lumenr, LLC, Matawan NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153698 is the FDA 510(k) clearance record for LumenR Tissue Retractor System, a class II device, cleared for Lumenr, LLC on under FDA product code ODB (Endoscopic Contamination Prevention Sheath). FDA's definition for product code ODB reads: "To protect an endoscope from contamination by providing a barrier between the body and the endoscope". FDA records list one 510(k) clearance for Lumenr, LLC. As of , FDA records show no recalls naming K153698.

Clearance record

Decision date
Received
(118 days to decision)
Product code
ODB Endoscopic Contamination Prevention Sheath
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Lumenr, LLC 253 Main St., Suite 270, Matawan NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODB

Trailing 12 months

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

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