Cleared Traditional

Rondek PGA Suture (Beige or Violet) (K180625) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180625 · Rk Manufacturing Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
62d
Days
Class 2
Risk

K180625 is an FDA 510(k) clearance for the Rondek PGA Suture (Beige or Violet). Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Rk Manufacturing Corporation (Danbury, US). The FDA issued a Cleared decision on May 10, 2018 after a review of 62 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4493 - 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 Rk Manufacturing Corporation devices

Submission Details

510(k) Number K180625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2018
Decision Date May 10, 2018
Days to Decision 62 days
Submission Type Traditional
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
53d faster than avg
Panel avg: 115d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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 Consultant

Clover Medical, LLC
John Gillespie

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 62
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K180625.
WEGO-PGA RAPID
K183004 · Foosin Medical Supplies Inc., Ltd. · Jan 2019
Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture
K181652 · Ethicon, Inc. · Sep 2018
Caprolon
K181320 · Resorba Medical GmbH · Sep 2018
StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
K173874 · Origami Surgical, LLC · May 2018
REXMONO, PDREX
K173779 · Sm Eng Co., Ltd. · Mar 2018
Monosyn Quick Synthetic Absorbable Surgical Suture
K171001 · Aesculap, Inc. · Oct 2017