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Cardionyl® 720202W

by Peters Surgical

Ref 720202W

Cardionyl® 720202W is a device classified as Class III in the EU and Class II in the US made by Peters Surgical, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-03661522024379), cleared under FDA 510(k) K913102 on 3 Aug 1992 and listed in FDA GUDID since 9 Jan 2020 (UDI-DI 03661522024379), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K913102

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03661522024379 Basic UDI-DI 03661522024379UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03661522024379 UDI-DI Date9 Jan 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK913102 Date3 Aug 1992DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03661522024379 registered 6 Nov 2026 Active
  • FDA 510(k) K913102 decided 3 Aug 1992 Active
  • FDA GUDID UDI-DI 03661522024379 listed 9 Jan 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K913102
  2. Listed FDA GUDID 03661522024379
  3. Registered EUDAMED B-03661522024379

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  • Withdrawn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
Cardionyl®
Generic name
Nylon suture, non-bioabsorbable, monofilament
Device name
Cardionyl
Model / reference
720202W
Primary DI / UDI-DI
03661522024379
Basic UDI-DI
B-03661522024379
510(k) Number
FDA product code
GAR
EMDN code
H010201010101 Polyamide monofilament with needle
GMDN term
Nylon suture, non-bioabsorbable, monofilament
Device class
Class III EUDAMED
Class II GUDID
Regulation number
878.5020
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

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.

Related devices

Category: Nylon suture, non-bioabsorbable, monofilament

Cleared under the same submission (K913102)

and 8 more cleared under K913102

Similar devices in this category

Other devices filed under POLYAMIDE MONOFILAMENT WITH NEEDLE.

Other devices from Peters Surgical

See all devices from Peters Surgical →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains animal tissues or cells
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)