510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253984Substantially Equivalent

Instrument Exit Point on Touch Surgery™ Aide

Medtronic, Inc., Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253984 is the FDA 510(k) clearance record for Instrument Exit Point on Touch Surgery™ Aide, a class II device, cleared for Covidien, LLC on under FDA product code SFE (Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation). FDA's definition for product code SFE reads: "To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor". FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K253984.

Clearance record

Decision date
Received
(174 days to decision)
Product code
SFE Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Covidien, LLC 15 Hampshire St., Mansfield MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SFE

Trailing 12 months
1 clearance under product code SFE in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SFE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260