510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941208Substantially Equivalent

Diagnostic Sleeve, Reducer Sleeve

New Eder Corp., Elk Groove Village IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941208 is the FDA 510(k) clearance record for DIAGNOSTIC SLEEVE, REDUCER SLEEVE, a class II device, cleared for New Eder Corp. on under FDA product code HET (Laparoscope, Gynecologic (And Accessories)). FDA records list 4 510(k) clearances for New Eder Corp., from to . As of , FDA records show no recalls naming K941208.

Clearance record

Decision date
Received
(95 days to decision)
Product code
HET Laparoscope, Gynecologic (And Accessories)
Regulation
21 CFR 884.1720
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
New Eder Corp. 1451-E Landmeier Rd., Elk Groove Village IL
510(k) summary
Statement
Third party review
No

Clearances, product code HET

Trailing 12 months

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

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