Cleared Traditional

K970493 - HYFRECATOR 2000

K970493 is an FDA 510(k) clearance for HYFRECATOR 2000, manufactured by Aspen Labs. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K970493 · Aspen Labs · General & Plastic Surgery device
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Apr 1997
Decision
79d
Days
Class 2
Risk

K970493 is an FDA 510(k) clearance for the HYFRECATOR 2000. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Aspen Labs (Centennial, US). The FDA issued a Cleared decision on April 30, 1997 after a review of 79 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 Aspen Labs devices

FDA 510(k) Submission Details - K970493

510(k) Number K970493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1997
Decision Date April 30, 1997
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
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 1504
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K970493.
UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM)
K964329 · Richard Wolf Medical Instruments Corp. · May 1997
ELECTROSURGICAL ELECTRODE
K970987 · Fusion Medical Technologies, Inc. · May 1997
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QA-ES
K971092 · Smith · Apr 1997
STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOW
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CABLE HOLDER, SUCTION TUBE HOLDER
K971040 · Contour Fabricators, Inc. · Apr 1997