PDO Max Threads PM19100W-SN

by Max Pdo Inc 2 variants

PDO Max Threads PM19100W-SN is a polyester suture (FDA Class II; FDA product code NEW, Suture, Surgical, Absorbable, Polydioxanone) made by Max Pdo Inc, cleared under FDA 510(k) K190245 on 4 Jun 2019 and listed in FDA GUDID since 23 Jun 2021 (UDI-DI 00850018324595), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00850018324595 UDI-DI	Date23 Jun 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated	NumberK190245	Date4 Jun 2019Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00850018324595
FDA 510(k) database 510(k) number K190245

Across registries

2 registries list this device

FDA 510(k) K190245 decided 4 Jun 2019 Active
FDA GUDID UDI-DI 00850018324595 listed 23 Jun 2021 Listed

Timeline

2 dated events

4 Jun 2019 Cleared FDA 510(k) K190245
23 Jun 2021 Listed FDA GUDID 00850018324595

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: PDO Max Threads
Generic name: Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Model / Ref / Catalog: PM19100W-SN

Primary DI / UDI-DI: 00850018324595
510(k) Number: K190245
FDA product code: NEW
GMDN term: Polyester suture, bioabsorbable, monofilament, non-antimicrobial

Device class: Class II
Regulation number: 878.4840
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Polyester suture, bioabsorbable, monofilament, non-antimicrobial.

Other devices from Max Pdo Inc

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PDO Max Threads PM21100L-FE-BP

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PDO Max Threads PM3025S-S

Class II

See all devices from Max Pdo Inc →

Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (8, all answered No)