510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843497Substantially Equivalent

Surgical Knives & Probes

Eder Instrument Co, Inc., Milwaukee, Wi 53202 / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843497 is the FDA 510(k) clearance record for SURGICAL KNIVES & PROBES, a class I device, cleared for Eder Instrument Co, Inc. on under FDA product code EMF (Knife, Surgical). FDA records list 10 510(k) clearances for Eder Instrument Co, Inc., from to . As of , FDA records show no recalls naming K843497.

Clearance record

Decision date
Received
(55 days to decision)
Product code
EMF Knife, Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Eder Instrument Co, Inc. 735 N. Water St., Milwaukee, Wi 53202
Third party review
No

Clearances, product code EMF

Trailing 12 months

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

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