Cleared Traditional

K012695 - VANGUARD REPROCESSED ARTHROSCOPIC WANDS

K012695 is an FDA 510(k) clearance for VANGUARD REPROCESSED ARTHROSCOPIC WANDS, manufactured by Vanguard Medical Concepts, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K012695 · Vanguard Medical Concepts, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
77d
Days
Class 2
Risk

K012695 is an FDA 510(k) clearance for the VANGUARD REPROCESSED ARTHROSCOPIC WANDS. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Vanguard Medical Concepts, Inc. (Lakeland, US). The FDA issued a Cleared decision on October 30, 2001 after a review of 77 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 Vanguard Medical Concepts, Inc. devices

FDA 510(k) Submission Details - K012695

510(k) Number K012695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date October 30, 2001
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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 1192
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K012695.
ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND
K013463 · Arthrocare Corp. · Nov 2001
REPROCESSED RF ARTHROSCOPY PROBES
K012679 · Sterilmed, Inc. · Nov 2001
VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS
K012700 · Vanguard Medical Concepts, Inc. · Nov 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
ARTHROCARE ELECTROSURGERY WANDS
K012519 · Arthrocare Corp. · Oct 2001
REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
K012625 · Alliance Medical Corp. · Oct 2001