Cleared Traditional

K010025 - ELECTRICATOR MODEL 26000

K010025 is an FDA 510(k) clearance for ELECTRICATOR MODEL 26000, manufactured by Dermatologic Lab & Supply, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K010025 · Dermatologic Lab & Supply, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
50d
Days
Class 2
Risk

K010025 is an FDA 510(k) clearance for the ELECTRICATOR MODEL 26000. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Dermatologic Lab & Supply, Inc. (Council Bluffs, US). The FDA issued a Cleared decision on February 22, 2001 after a review of 50 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.

FDA 510(k) Submission Details - K010025

510(k) Number K010025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2001
Decision Date February 22, 2001
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
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 2250
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K010025.
ENDIUS BIPOLAR SHEATH
K003897 · Endius, Inc. · Mar 2001
INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF
K003717 · Tekno Medical Optik-Chirurgie GmbH & Co. · Mar 2001
ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP
K010444 · C.R. Bard, Inc. · Feb 2001
CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400
K010210 · Curon Medical, Inc. · Feb 2001
MICTEC ENDOSCOPES AND ACCESSORIES
K002877 · Dufner Instrumente GmbH · Feb 2001
CLEAN SCRAPE
K003773 · Webb Research Ii, Inc. · Feb 2001
K010025 · ELECTRICATOR MODEL 26000
Download PDF FDA Summary Dermatologic Lab & Su…