510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220420Substantially Equivalent

Saffron Fixation System

MEDLINE INDUSTRIES, LP - Northfield, Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220420 is the FDA 510(k) clearance record for Saffron Fixation System, a class II device, cleared for Coloplast A/S on under FDA product code PBQ (Fixation, Non-Absorbable Or Absorbable, For Pelvic Use). FDA's definition for product code PBQ reads: "Attaching suture or stapling ligaments of the pelvic floor". FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K220420.

Clearance record

Decision date
Received
(116 days to decision)
Product code
PBQ Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Coloplast A/S 1601 W. River Rd. N., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PBQ

Trailing 12 months
1 clearance under product code PBQ in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PBQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260