Cleared Traditional

K912070 - SIEMENS RADIOTOM 904 & 904E ELECTROSURG...

K912070 is the FDA 510(k) clearance for SIEMENS RADIOTOM 904 & 904E ELECTROSURG... by Siemens Medical Electronics. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 349-day FDA review.

K912070 · Siemens Medical Electronics · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 1992
Decision
349d
Days
Class 2
Risk

K912070 is an FDA 510(k) clearance for the SIEMENS RADIOTOM 904 & 904E ELECTROSURGERY UNIT. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Siemens Medical Electronics (Danvers, US). The FDA issued a Cleared decision on April 23, 1992 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K912070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1991
Decision Date April 23, 1992
Days to Decision 349 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
234d slower than avg
Panel avg: 115d · This submission: 349d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 893
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K912070.
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MULTI USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT
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GENESIS ELECTROSURGICAL UNIT
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MODELS E2502B/E2525 REUSABLE HANDSWITCHING PENCILS
K914400 · Valleylab, Inc. · Oct 1991
MODELS UES-10 & PSD-10
K911904 · Olympus Corp. · Jul 1991