Cleared Traditional

K220420 - Saffron Fixation System (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220420 · Coloplast A/S · Obstetrics & Gynecology device
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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.

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Submission Details

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.

Device Classification

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.