Cleared Traditional

K973701 - SOMNUS TISSUE COAGULATING ELECTRODE

K973701 is an FDA 510(k) clearance for SOMNUS TISSUE COAGULATING ELECTRODE, manufactured by Somnus Medical Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K973701 · Somnus Medical Technologies, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jan 1998
Decision
123d
Days
Class 2
Risk

K973701 is an FDA 510(k) clearance for the SOMNUS TISSUE COAGULATING ELECTRODE. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Somnus Medical Technologies, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on January 30, 1998 after a review of 123 days - within the typical 510(k) review window.

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. 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 Somnus Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K973701

510(k) Number K973701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1997
Decision Date January 30, 1998
Days to Decision 123 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 115d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1468
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K973701.
FIRE STICK
K973197 · H.S. Intl. Co., Inc. · Feb 1998
AARON 1200 HIGH FREQUENCY ELECTROSURGICL GENERATOR A1200, A1200/240
K980366 · Aaron Medical Industries · Feb 1998
3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130)
K974553 · 3M Healthcare · Feb 1998
3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C)
K974279 · 3M Healthcare · Jan 1998
MIS ELECTROSURGICAL ELECTRODE
K971829 · E-Tek, Inc. · Jan 1998
ORATEC MODEL ENDOTAC PROBE
K972358 · Oratec Interventions, Inc. · Jan 1998