Cleared Traditional

SURGVIEW INTEGRATED VISUALIZATION SYSTEM (K082293) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082293 · Biovision Technologies, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
28d
Days
Class 2
Risk

K082293 is an FDA 510(k) clearance for the SURGVIEW INTEGRATED VISUALIZATION SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Biovision Technologies, LLC (Golden, US). The FDA issued a Cleared decision on September 9, 2008 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory 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 Biovision Technologies, LLC devices

Submission Details

510(k) Number K082293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2008
Decision Date September 09, 2008
Days to Decision 28 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 158
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K082293.
KYPHON ELEMENT Inflatable Bone Tamp
K151532 · Medtronic, Inc. · Jul 2015
KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP
K093471 · KARL STORZ Endoscopy-America, Inc. · Oct 2010
ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE
K083707 · Arthrex, Inc. · Aug 2009
SMITH & NEPHEW ARTHROSCOPE
K072675 · Smith & Nephew, Inc. · Oct 2007
SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM
K062849 · Smith & Nephew, Inc. · Jan 2007
SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM
K051326 · Smith & Nephew, Inc. · Jun 2005