Cleared Special

K000170 - SECCA TUBULAR ELECTRODE DEVICE

K000170 is an FDA 510(k) clearance for SECCA TUBULAR ELECTRODE DEVICE, manufactured by Conway Stuart Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 27-day FDA review.

K000170 · Conway Stuart Medical, Inc. · General & Plastic Surgery device
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Feb 2000
Decision
27d
Days
Class 2
Risk

K000170 is an FDA 510(k) clearance for the SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Conway Stuart Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 14, 2000 after a review of 27 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.

View all Conway Stuart Medical, Inc. devices

FDA 510(k) Submission Details - K000170

510(k) Number K000170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2000
Decision Date February 14, 2000
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
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 1207
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K000170.
DYONICS ELECTROBLADE
K994365 · Smith & Nephew, Inc. · Mar 2000
E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE
K994428 · Valleylab, Inc. · Mar 2000
ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PLASMA WAND
K000228 · Arthrocare Corp. · Feb 2000
ENTEC REFLEX WAND 55, MODEL E4055-00
K000036 · Arthrocare Corp. · Feb 2000
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA SCALPEL GS, TURBOVAC GS
K000074 · Arthrocare Corp. · Feb 2000
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINEWANDS
K000044 · Arthrocare Corp. · Feb 2000