510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K912265Substantially Equivalent

Medilase Semi-Rigid Instrod Sheath Series Ae1000

Medical Laser, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912265 is the FDA 510(k) clearance record for MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000, a class II device, cleared for Medical Laser, Inc. on under FDA product code FED (Endoscopic Access Overtube, Gastroenterology-Urology). FDA's definition for product code FED reads: "To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation". FDA records list 8 510(k) clearances for Medical Laser, Inc., from to . As of , FDA records show no recalls naming K912265.

Clearance record

Decision date
Received
(141 days to decision)
Product code
FED Endoscopic Access Overtube, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medical Laser, Inc. 2605 Fernbrook Ln., Minneapolis MN
510(k) summary
Statement
Third party review
No

Clearances, product code FED

Trailing 12 months
5 clearances under product code FED in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FED, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20260
August 20260
September 20263
October 20260