Cleared Special

HS Fiber (K190817) - FDA 510(k) Clearance

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

K190817 · Riverpoint Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
30d
Days
Class 2
Risk

K190817 is an FDA 510(k) clearance for the HS Fiber. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on May 1, 2019 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 Riverpoint Medical devices

Submission Details

510(k) Number K190817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2019
Decision Date May 01, 2019
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.

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 173
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K190817.
Polyethylene
K260775 · Teleflex Medical, LLC · May 2026
HyperSuture All Green Extension Line
K254275 · Threadstone, LLC · Mar 2026
Meniscus Versaflex
K254188 · GM Dos Reis Industria e Comercio Ltda. · Feb 2026
Pre-Sutured Tendon
K253145 · Rti Surgical, Inc. · Oct 2025
ProZip Knotless Implant
K253024 · Riverpoint Medical · Oct 2025
PowerKnot High Strength Sutures
K252225 · Medacta International S.A. · Sep 2025