510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K926217Substantially Equivalent

Terumo Angiographic Catheter for Laporoscopic Use

Terumo Medical Corp., Elkton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926217 is the FDA 510(k) clearance record for TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE, a class I device, cleared for Terumo Medical Corp. on under FDA product code GBZ (Catheter, Cholangiography). FDA records list 157 510(k) clearances for Terumo Medical Corp., from to . As of , FDA records show no recalls naming K926217.

Clearance record

Decision date
Received
(215 days to decision)
Product code
GBZ Catheter, Cholangiography
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Terumo Medical Corp. 125 Blue Ball Rd., Elkton MD
510(k) summary
Statement
Third party review
No

Clearances, product code GBZ

Trailing 12 months

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

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