510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821708Substantially Equivalent

Nagashima Light Source Unit Sl-4

Kelleher Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821708 is the FDA 510(k) clearance record for NAGASHIMA LIGHT SOURCE UNIT SL-4, a class II device, cleared for Kelleher Corp. on under FDA product code EQN (Laryngoscope, Nasopharyngoscope). FDA's definition for product code EQN reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 94 510(k) clearances for Kelleher Corp., from to . As of , FDA records show no recalls naming K821708.

Clearance record

Decision date
Received
(16 days to decision)
Product code
EQN Laryngoscope, Nasopharyngoscope
Regulation
21 CFR 874.4760
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Kelleher Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EQN

Trailing 12 months
1 clearance under product code EQN in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EQN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260