Cleared Traditional

K003773 - CLEAN SCRAPE

K003773 is an FDA 510(k) clearance for CLEAN SCRAPE, manufactured by Webb Research Ii, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K003773 · Webb Research Ii, Inc. · General & Plastic Surgery device
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Feb 2001
Decision
58d
Days
Class 2
Risk

K003773 is an FDA 510(k) clearance for the CLEAN SCRAPE. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Webb Research Ii, Inc. (Philadelphia, US). The FDA issued a Cleared decision on February 2, 2001 after a review of 58 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 - K003773

510(k) Number K003773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2000
Decision Date February 02, 2001
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
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 2306
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K003773.
ELECTRICATOR MODEL 26000
K010025 · Dermatologic Lab & Supply, 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
RITA STARBURST XLI ELECTROSURGICAL DEVICE
K010060 · Rita Medical Systems · Jan 2001
ELECTROSURGICAL PROBES AND DEVICES-GELTX
K002269 · Ximed/Prosure/Injectx · Jan 2001
ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045
K003462 · Erbe USA, Inc. · Jan 2001
K003773 · CLEAN SCRAPE
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