Cleared Traditional

K003471 - MAGNA TEK ESU-400

K003471 is an FDA 510(k) clearance for MAGNA TEK ESU-400, manufactured by Huttinger Medizintechnik GmbH & CO KG. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K003471 · Huttinger Medizintechnik GmbH & CO KG · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
12d
Days
Class 2
Risk

K003471 is an FDA 510(k) clearance for the MAGNA TEK ESU-400. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Huttinger Medizintechnik GmbH & CO KG (Umkirch, DE). The FDA issued a Cleared decision on November 20, 2000 after a review of 12 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K003471

510(k) Number K003471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2000
Decision Date November 20, 2000
Days to Decision 12 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 115d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Tuv Product Service, Inc.
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 2306
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K003471.
REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE
K002987 · Xomed, Inc. · Dec 2000
CLEARGLIDE PRECISION BIPOLAR DEVICE
K003587 · Ethicon, Inc. · Dec 2000
BAYONET FORCEPS BIPOLAR IRRIGATING
K002752 · Q2 Medical · Nov 2000
TISSUELINK MONOPOLAR FLOATING BALL'
K002680 · Tissuelink Medical, Inc. · Nov 2000
PILLING E-FRAZIER BIPOLAR SUCTION TUBE
K002582 · Pilling · Nov 2000
PLASMAKINETIC GENERATOR
K003060 · Everest Medical Corp. · Oct 2000

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K003471 · MAGNA TEK ESU-400
Download PDF FDA Summary Huttinger Medizintech…