Cleared Traditional

K843498 - BIPOLAR SUCTION ELECTRODE

K843498 is an FDA 510(k) clearance for BIPOLAR SUCTION ELECTRODE, manufactured by Eder Instrument Co, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GET cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K843498 · Eder Instrument Co, Inc. · General & Plastic Surgery device
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Dec 1984
Decision
99d
Days
Class 1
Risk

K843498 is an FDA 510(k) clearance for the BIPOLAR SUCTION ELECTRODE. Classified as Motor, Surgical Instrument, Pneumatic Powered (product code GET), Class I - General Controls.

Submitted by Eder Instrument Co, Inc. (Milwaukee, Wi 53202, US). The FDA issued a Cleared decision on December 14, 1984 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Eder Instrument Co, Inc. devices

FDA 510(k) Submission Details - K843498

510(k) Number K843498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1984
Decision Date December 14, 1984
Days to Decision 99 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 115d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

GET Device Classification - Class 1, General Controls

Product Code GET Motor, Surgical Instrument, Pneumatic Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GET Motor, Surgical Instrument, Pneumatic Powered

All 11
Devices cleared under the same product code (GET) and FDA review panel - the closest regulatory comparables to K843498.
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MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP
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STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II
K863447 · Stryker Corp. · Sep 1986
SURG-A-STAT VASECTOMY TIP
K840370 · Suncoast Medical Manufacturers, Inc. · Jul 1984
HALL OSTEON
K833187 · Amsco Co. · Oct 1983
HALL DRILL/REAMER
K832186 · Amsco Co. · Aug 1983