510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955717Substantially Equivalent

Endoscope Introducer Kit

Mitsubishi Cable America, Inc., Villa Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955717 is the FDA 510(k) clearance record for ENDOSCOPE INTRODUCER KIT, a class II device, cleared for Mitsubishi Cable America, Inc. on under FDA product code FDE (Laparoscopy Kit). FDA's definition for product code FDE reads: "This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the...". FDA records list 3 510(k) clearances for Mitsubishi Cable America, Inc., from to . As of , FDA records show no recalls naming K955717.

Clearance record

Decision date
Received
(122 days to decision)
Product code
FDE Laparoscopy Kit
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mitsubishi Cable America, Inc. 10551 Wulff Dr., Villa Park CA
510(k) summary
Summary
Third party review
No

Clearances, product code FDE

Trailing 12 months

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

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