Cleared Traditional

K012679 - REPROCESSED RF ARTHROSCOPY PROBES

K012679 is the FDA 510(k) clearance for REPROCESSED RF ARTHROSCOPY PROBES by Sterilmed, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K012679 · Sterilmed, Inc. · General & Plastic Surgery device
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Nov 2001
Decision
86d
Days
Class 2
Risk

K012679 is an FDA 510(k) clearance for the REPROCESSED RF ARTHROSCOPY PROBES. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on November 8, 2001 after a review of 86 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 Sterilmed, Inc. devices

Submission Details

510(k) Number K012679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date November 08, 2001
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
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 1167
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K012679.
INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY
K013416 · Intuitive Surgical, Inc. · Jan 2002
REPROCESSED SOFT TISSUE ABLATORS
K012631 · Alliance Medical Corp. · Dec 2001
ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND
K013463 · Arthrocare Corp. · Nov 2001
VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS
K012700 · Vanguard Medical Concepts, Inc. · Nov 2001
VANGUARD REPROCESSED ARTHROSCOPIC WANDS
K012695 · Vanguard Medical Concepts, Inc. · Oct 2001
MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166
K013348 · Erbe USA, Inc. · Oct 2001