Cleared Traditional

HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL (K001159) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K001159 · Conmedcorp · General & Plastic Surgery device
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Jun 2000
Decision
58d
Days
Class 2
Risk

K001159 is an FDA 510(k) clearance for the HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING AC.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Conmedcorp (Centennial, US). The FDA issued a Cleared decision on June 7, 2000 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.

View all Conmedcorp devices

Submission Details

510(k) Number K001159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date June 07, 2000
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
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.

Device Classification

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 700
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K001159.
CLEARGLIDE PRECISION BIPOLAR DEVICE
K003587 · Ethicon, Inc. · Dec 2000
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD
K001936 · Arthrocare Corp. · Jul 2000
ARTHROCARE FLOW CONTROL UNIT
K001904 · Arthrocare Corp. · Jul 2000
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C
K001302 · Arthrocare Corp. · May 2000
SOVEREIGN BIPOLAR INSTRUMENTS
K001330 · Aesculap, Inc. · May 2000
ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01
K000778 · Arthrocare Corp. · May 2000