Cleared Special

K001438 - SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR

K001438 is an FDA 510(k) clearance for SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR, manufactured by Somnus Medical Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 8-day FDA review.

K001438 · Somnus Medical Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
8d
Days
Class 2
Risk

K001438 is an FDA 510(k) clearance for the SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR. 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 16, 2000 after a review of 8 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K001438

510(k) Number K001438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2000
Decision Date May 16, 2000
Days to Decision 8 days
Submission Type Special
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
107d faster than avg
Panel avg: 115d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

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 2201
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K001438.
HM-930 ELECTROSURGICAL UNIT
K993991 · Hill-Med, Inc. · May 2000
SURGITRON IEC II
K001253 · Ellman Intl., Inc. · May 2000
GEIGER NEEDLE ADAPTER, MODEL 406
K001029 · Geiger Medical Technologies, Inc. · May 2000
COLORADO MICRODISSECTION NEEDLE
K000348 · Stryker Leibinger · May 2000
ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01
K000778 · Arthrocare Corp. · May 2000
ACTIVE ELECTRODE MONITORING SYSTEM
K000480 · Electroscope, Inc. · May 2000
K001438 · SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR
Download PDF FDA Summary Somnus Medical Techno…