Cleared Traditional

K843497 - SURGICAL KNIVES & PROBES
(FDA 510(k) Clearance)

K843497 · Eder Instrument Co, Inc. · General & Plastic Surgery device

Oct 1984

Decision

55d

Days

Class 1

Risk

K843497 is an FDA 510(k) clearance for the SURGICAL KNIVES & PROBES. This device is classified as a Knife, Surgical (Class I - General Controls, product code EMF).

Submitted by Eder Instrument Co, Inc. (Milwaukee, Wi 53202, US). The FDA issued a Cleared decision on October 31, 1984, 55 days after receiving the submission on September 6, 1984.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K843497 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 06, 1984
Decision Date	October 31, 1984
Days to Decision	55 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—