510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132039Substantially Equivalent

Ergo-Flex Laryngo-Nasopharyngoscope Ef-N and Ef-N Slim

JEDMED Instrument Company, Saint Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132039 is the FDA 510(k) clearance record for ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM, a class II device, cleared for Jedmed Instrument Co. 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 93 510(k) clearances for Jedmed Instrument Co., from to . As of , FDA records show no recalls naming K132039.

Clearance record

Decision date
Received
(234 days to decision)
Product code
EQN Laryngoscope, Nasopharyngoscope
Regulation
21 CFR 874.4760
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Jedmed Instrument Co. 5416 Jedmed Ct., Saint Louis MO
510(k) summary
Summary PDF
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