Cleared Special

K153096 - LARIAT RS Suture Delivery Device (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K153096 · Sentreheart, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
30d
Days
Class 2
Risk

K153096 is an FDA 510(k) clearance for the LARIAT RS Suture Delivery Device. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Sentreheart, Inc. (Redwood City, US). The FDA issued a Cleared decision on November 25, 2015 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sentreheart, Inc. devices

Submission Details

510(k) Number K153096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2015
Decision Date November 25, 2015
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 114d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 172
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