Cleared Traditional

K060721 - LARIAT LOOP APPLICATOR

K060721 is an FDA 510(k) clearance for LARIAT LOOP APPLICATOR, manufactured by Sentreheart. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K060721 · Sentreheart · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Jun 2006
Decision
77d
Days
Class 2
Risk

K060721 is an FDA 510(k) clearance for the LARIAT LOOP APPLICATOR. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Sentreheart (Palo Alto, US). The FDA issued a Cleared decision on June 2, 2006 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 878.5000 - 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 Sentreheart devices

FDA 510(k) Submission Details - K060721

510(k) Number K060721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2006
Decision Date June 02, 2006
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.

GAT Device Classification - Class 2, Special Controls

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 126
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K060721.
TUFFLEX POLYESTER SUTURE
K063194 · Axya Medical, Inc. · Dec 2006
AXYAFLEX POLYESTER SUTURE
K060165 · Axya Medical, Inc. · Sep 2006
TENOLIG
K060367 · Fournitures Hospitalieres Industrie · Aug 2006
ALLOFIX ANCHOR
K053339 · Musculoskeletal Transplant Foundation · Mar 2006
SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE
K052652 · Smith & Nephew, Inc. · Oct 2005
MTF ALLOGRAFT ANCHOR
K042038 · Musculoskeletal Transplant Foundation · Dec 2004