Cleared Special

K152795 - RiverLon (Nylon) Suture

K152795 is an FDA 510(k) clearance for RiverLon (Nylon) Suture, manufactured by Riverpoint Medical. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Special 510(k) pathway after a 30-day FDA review.

K152795 · Riverpoint Medical · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
30d
Days
Class 2
Risk

K152795 is an FDA 510(k) clearance for the RiverLon (Nylon) Suture. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on October 28, 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 878.5020 - 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.

FDA 510(k) Submission Details - K152795

510(k) Number K152795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2015
Decision Date October 28, 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

GAR Device Classification - Class 2, Special Controls

Product Code GAR Suture, Nonabsorbable, Synthetic, Polyamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5020
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 - GAR Suture, Nonabsorbable, Synthetic, Polyamide

All 56
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K152795.
Crownjun Nylon Suture
K192420 · Kono Seisakusho Co., Ltd. · May 2020
REXLON, REXSIL
K161633 · Sm Eng Co., Ltd. · Mar 2017
Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture
K151165 · Aesculap, Inc. · Feb 2016
VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
K123034 · Unilene Sac · May 2013
KUMAR T-ANCHORS HERNIA SET
K081366 · Nashville Surgical Instruments · Jul 2008
FSSB NYLON SURGICAL SUTURES
K060471 · Fssb Chirurgische Nadeln GmbH · Jul 2006
K152795 · RiverLon (Nylon) Suture
Download PDF FDA Summary Riverpoint Medical