Cleared Traditional

K980588 - CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K980588 · Clarus Medical Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
182d
Days
Class 1
Risk

K980588 is an FDA 510(k) clearance for the CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 18, 1998 after a review of 182 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Clarus Medical Systems, Inc. devices

Submission Details

510(k) Number K980588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1998
Decision Date August 18, 1998
Days to Decision 182 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 114d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAD Retractor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.