510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834540Substantially Equivalent

Op-Con Surgical Instrument #9

Imm Enterprises, Ltd., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834540 is the FDA 510(k) clearance record for OP-CON SURGICAL INSTRUMENT #9, a class I device, cleared for Imm Enterprises , Ltd. on under FDA product code KBN (Gag, Mouth). FDA records list 52 510(k) clearances for Imm Enterprises , Ltd., from to . As of , FDA records show no recalls naming K834540.

Clearance record

Decision date
Received
(96 days to decision)
Product code
KBN Gag, Mouth
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Imm Enterprises , Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KBN

Trailing 12 months

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

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