510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230752Substantially Equivalent

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)

FUJIFILM Healthcare Americas Corporation, Lexington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230752 is the FDA 510(k) clearance record for Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A), a class II device, cleared for FUJIFILM Healthcare Americas Corporation 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 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K230752.

Clearance record

Decision date
Received
(182 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
FUJIFILM Healthcare Americas Corporation 81 Hartwell Ave., Lexington MA
510(k) summary
Summary PDF
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