Cleared Traditional

BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL (K970809) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970809 · Somnus Medical Technologies, Inc. · General & Plastic Surgery device
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Jun 1997
Decision
105d
Days
Class 2
Risk

K970809 is an FDA 510(k) clearance for the BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL. 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 June 18, 1997 after a review of 105 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

Submission Details

510(k) Number K970809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1997
Decision Date June 18, 1997
Days to Decision 105 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
10d faster than avg
Panel avg: 115d · This submission: 105d
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 570
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K970809.
KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES
K972497 · KARL STORZ Endoscopy-America, Inc. · Aug 1997
AESCULAP JET IRRIGATION SYSTEM
K971310 · Aesculap, Inc. · Jul 1997
3M UNIVERSAL ELECTROSURGICAL PAD SPLIT/SOLID(9130&9160)
K971446 · 3M Company · Jul 1997
AESCULAP MODULAR MONOPOLAR ELECTRODES
K970541 · Aesculap, Inc. · Mar 1997
MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE
K963783 · Ethicon, Inc. · Nov 1996
MIRROR FINISH BIPOLAR FORCEPS
K963499 · Johnson & Johnson Professionals, Inc. · Oct 1996