510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K902736Substantially Equivalent

Nm Injection Needles

Olympus Corp., Lake Success NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902736 is the FDA 510(k) clearance record for NM INJECTION NEEDLES, a class II device, cleared for Olympus Corp. on under FDA product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology). FDA's definition for product code FBK reads: "inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue". FDA records list 149 510(k) clearances for Olympus Corp., from to . As of , FDA records show no recalls naming K902736.

Clearance record

Decision date
Received
(64 days to decision)
Product code
FBK Endoscopic Injection Needle, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Corp. 4 Nevada Dr., Lake Success NY
Third party review
No

Clearances, product code FBK

Trailing 12 months
3 clearances under product code FBK in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FBK, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260