510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834177Substantially Equivalent

H.r. Jakobi Surg. Instruments #4 30/31

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

K834177 is the FDA 510(k) clearance record for H.R. JAKOBI SURG. INSTRUMENTS #4 30/31, a class I device, cleared for Imm Enterprises , Ltd. on under FDA product code HGE (Amniotome). FDA records list 52 510(k) clearances for Imm Enterprises , Ltd., from to . As of , FDA records show no recalls naming K834177.

Clearance record

Decision date
Received
(36 days to decision)
Product code
HGE Amniotome
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Imm Enterprises , Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HGE

Trailing 12 months

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

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