Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K173495Substantially Equivalent

Single Use Hot Biopsy Forceps FD-231

Olympus Medical Systems Corp., Hachioji-Shi, JP / Traditional, Substantially Equivalent

K173495 is the FDA 510(k) clearance record for Single Use Hot Biopsy Forceps FD-231, a class II device, cleared for Olympus Medical Systems Corp. on under FDA product code QEC (Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree). FDA's definition for product code QEC reads: "An endoscopic electrosurgical forceps and accessories used with an endoscope to electrosurgically collect tissue for biopsy and to perform electrosurgical hemostasis within the tracheobronchial tree". FDA records list 186 510(k) clearances for Olympus Medical Systems Corp., from to . As of , FDA records show no recalls naming K173495.

Clearance record

Decision date
Received
(382 days to decision)
Product code
QEC Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEC

Trailing 12 months

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

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