Cleared Traditional

K220420 - Saffron Fixation System

K220420 is an FDA 510(k) clearance for Saffron Fixation System, manufactured by Coloplast A/S. The device is a Class 2 Obstetrics & Gynecology device with product code PBQ cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K220420 · Coloplast A/S · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
116d
Days
Class 2
Risk

K220420 is an FDA 510(k) clearance for the Saffron Fixation System. Classified as Fixation, Non-absorbable Or Absorbable, For Pelvic Use (product code PBQ), Class II - Special Controls.

Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on June 10, 2022 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Coloplast A/S devices

FDA 510(k) Submission Details - K220420

510(k) Number K220420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2022
Decision Date June 10, 2022
Days to Decision 116 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 160d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PBQ Device Classification - Class 2, Special Controls

Product Code PBQ Fixation, Non-absorbable Or Absorbable, For Pelvic Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
Definition Attaching Suture Or Stapling Ligaments Of The Pelvic Floor.
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - PBQ Fixation, Non-absorbable Or Absorbable, For Pelvic Use

All 7
Devices cleared under the same product code (PBQ) and FDA review panel - the closest regulatory comparables to K220420.
Mendit
K260380 · Escala Medical, Ltd. · Mar 2026
Apyx
K230730 · Escala Medical · Jul 2023
Apyx
K213783 · Escala Medical · Apr 2022
NeuGuide
K160569 · Pop Medical Solutions · Jul 2016
ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
K130059 · Ibi Israel Biomedical Innovations , Ltd. · Jul 2013
ANCHORSURE
K120831 · Neomedic International S.L. · Oct 2012