Cleared Traditional

K000720 - SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE

K000720 is an FDA 510(k) clearance for SOMNUS DISPOSABLE TISSUE COAGULATING EL..., 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 88-day FDA review.

K000720 · Somnus Medical Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
88d
Days
Class 2
Risk

K000720 is an FDA 510(k) clearance for the SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR .... 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 May 30, 2000 after a review of 88 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.

View all Somnus Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K000720

510(k) Number K000720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2000
Decision Date May 30, 2000
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 K000720.
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SOVEREIGN BIPOLAR INSTRUMENTS
K001330 · Aesculap, Inc. · May 2000
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K001438 · Somnus Medical Technologies, Inc. · May 2000