510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935247Substantially Equivalent

Jedmed Compact Endoscopic Beamsplitter

JEDMED Instrument Company, St.Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935247 is the FDA 510(k) clearance record for JEDMED COMPACT ENDOSCOPIC BEAMSPLITTER, a class I device, cleared for Jedmed Instrument Co. on under FDA product code FEA (Attachment, Teaching, For Endoscope). FDA records list 93 510(k) clearances for Jedmed Instrument Co., from to . As of , FDA records show no recalls naming K935247.

Clearance record

Decision date
Received
(109 days to decision)
Product code
FEA Attachment, Teaching, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Jedmed Instrument Co. 6096 Lemay Ferry Rd., St.Louis MO
510(k) summary
Statement
Third party review
No

Clearances, product code FEA

Trailing 12 months

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

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