Skip to content

Saffron Fixation System

by Coloplast A/S

510(k) K220420

Saffron Fixation System is a Class II device made by Coloplast A/S, cleared under FDA 510(k) K220420 on 10 Jun 2022, active as of 9 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 9 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 9 Oct 2026.

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK220420 Date10 Jun 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PBQ
Device class
Class II
Regulation
21 CFR Part 884.4530
Advisory committee
Obstetrics/Gynecology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K220420

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K220420
UDI-DISize and differences
Saffron 520340
Coloplast A/S
520340 / 52034005708932757423
Single use: no
On the market
Saffron 520350
Coloplast A/S
520350 / 52035005708932757690
Single use: yes
On the market

Similar devices

Other devices filed under FDA product code PBQ (Fixation, Non-Absorbable Or Absorbable, For Pelvic Use).

Other devices from Coloplast A/S

See all devices from Coloplast A/S →