Cleared Traditional

K980588 - CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SIT...

K980588 is an FDA 510(k) clearance for CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SIT..., manufactured by Clarus Medical Systems, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 182-day FDA review.

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

FDA 510(k) Submission Details - K980588

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
67d slower than avg
Panel avg: 115d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

GAD Device Classification - Class 1, General Controls

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.

Regulatory Peers - GAD Retractor

All 40
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K980588.
OTELO LL
K151104 · Spineart · Jan 2016
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
K132645 · Medtronic, Inc. · Oct 2013
QUADRANT RETRACTOR SYSTEM
K043602 · Medtronic Sofamor Danek · Feb 2005
LUNG RETRACTORS: DAVIDSON, SEMB
K930316 · Thomasville Medical Assoc. · Feb 1994
THOROCOSCOPY SELF-RETAINING RETRACTOR
K926585 · T. Korossurgical Instruments Corp. · Aug 1993
AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR
K914190 · United States Surgical, A Division of Tyco Healthc · May 1992