Cleared Traditional

K000060 - GEL MARK BIOPSY SITE MARKER

K000060 is the FDA 510(k) clearance for GEL MARK BIOPSY SITE MARKER by Senorx, Inc.. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K000060 · Senorx, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2000
Decision
77d
Days
Class 2
Risk

K000060 is an FDA 510(k) clearance for the GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Senorx, Inc. (Irvine, US). The FDA issued a Cleared decision on March 27, 2000 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 878.4750 - 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 Senorx, Inc. devices

Submission Details

510(k) Number K000060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2000
Decision Date March 27, 2000
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
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.

Device Classification

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 - GDW Staple, Implantable

All 158
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K000060.
ENDOANCHOR AND OPENANCHOR
K013749 · Ethicon Endo-Surgery, Inc. · Feb 2002
AUTO SUTURE SURGICAL STAPLES
K013860 · United States Surgical, A Division of Tyco Healthc · Dec 2001
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K001895 · United States Surgical, A Division of Tyco Healthc · Dec 2000
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
K991030 · Ethicon Endo-Surgery, Inc. · May 1999
AUTO SUTURE SITE MARKER CLIP
K983400 · United States Surgical, A Division of Tyco Healthc · Feb 1999
PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS
K983536 · Ethicon Endo-Surgery, Inc. · Dec 1998