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Quill PDO

by Surgical Specialties Mexico S. DE R.L. DE C.V. 119 variants

Ref VLP-4140Model Quill™ PDO (Polydioxanone)

Quill PDO (VLP-4140) is a device classified as Class III in the EU and Class II in the US made by Surgical Specialties México, S. de R.L. de C.V., registered in EUDAMED on 2 Jul 2024 (Basic UDI-DI B-00848782040094), cleared under FDA 510(k) K132268 on 23 Aug 2013 and listed in FDA GUDID since 5 Apr 2021 (UDI-DI 00848782040094), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132268

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00848782040094 Basic UDI-DI 00848782040094UDI-DIDate2 Jul 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00848782040094 UDI-DI Date5 Apr 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK132268 Date23 Aug 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00848782040094 registered 2 Jul 2024 Active
  • FDA 510(k) K132268 decided 23 Aug 2013 Active
  • FDA GUDID UDI-DI 00848782040094 listed 5 Apr 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132268
  2. Listed FDA GUDID 00848782040094
  3. Registered EUDAMED B-00848782040094

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Quill PDO EUDAMED
Quill GUDID
Generic name
Barbed polyester suture, non-antimicrobial
Model / Ref / Catalog
Quill™ PDO (Polydioxanone), VLP-4140
Primary DI / UDI-DI
00848782040094
Basic UDI-DI
B-00848782040094
510(k) Number
FDA product code
NEW
EMDN code
H010101010101 Polydioxanone monofilament with needle for open surgery
GMDN term
Barbed polyester suture, non-antimicrobial
Device class
Class III EUDAMED
Class II GUDID
Regulation number
878.4840
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
MX-MF-000015841
Authorised representative
FSSB Chirurgische Nadeln GmbH DE-AR-000005767

Related devices

Category: Polyester suture, bioabsorbable, monofilament, non-antimicrobial

Similar devices in this category

Other devices filed under POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY.

Other devices from Surgical Specialties México, S. de R.L. de C.V.

See all devices from Surgical Specialties México, S. de R.L. de C.V. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)