Cleared Traditional

SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE (K961133) - FDA 510(k) Clearance

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

K961133 · Somnus Medical Technologies, Inc. · General & Plastic Surgery device
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Jul 1996
Decision
111d
Days
Class 2
Risk

K961133 is an FDA 510(k) clearance for the SOMNUS MEDICAL TECH. MALLEABLE 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. (Cupertino, US). The FDA issued a Cleared decision on July 10, 1996 after a review of 111 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 K961133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1996
Decision Date July 10, 1996
Days to Decision 111 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 115d · This submission: 111d
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 K961133.
MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE
K963783 · Ethicon, Inc. · Nov 1996
MIRROR FINISH BIPOLAR FORCEPS
K963499 · Johnson & Johnson Professionals, Inc. · Oct 1996
AUTO SUTURE SURGIWAND
K961771 · United States Surgical, A Division of Tyco Healthc · Sep 1996
KARL STORZ REMORGIDA FORCEPS
K962030 · KARL STORZ Endoscopy-America, Inc. · Jun 1996
ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE
K960476 · Ethicon, Inc. · Apr 1996
BIOPOLAR FORCEPS LINE
K954851 · Johnson & Johnson Professionals, Inc. · Nov 1995