Skip to content

Optime® 18B15B

by Peters Surgical

Part of a family of 297 devices: see the family page

Ref 18B15B

Optime® 18B15B 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-03661522040812), cleared under FDA 510(k) K062366 on 2 Oct 2006 and listed in FDA GUDID since 9 Jan 2020 (UDI-DI 03661522040812), active as of 7 Nov 2026.

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

CE MDR CE MDD 510(k)

Valid until

30 Jul 2028

CE MDR certificate

FDA recalls

None found

in data synced 7 Nov 2026

Documents

1 certificate

Certifier GMED SAS

510(k) K062366

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/MDR EUDAMED NumberB-03661522040812 Basic UDI-DI 03661522040812UDI-DIDate6 Nov 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-03661522040812 Basic UDI-DI 03661522040812UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03661522040812 UDI-DI Date9 Jan 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK062366 Date2 Oct 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03661522040812 registered 6 Nov 2026 Active· +1 more in the status table
  • FDA 510(k) K062366 decided 2 Oct 2006 Active
  • FDA GUDID UDI-DI 03661522040812 listed 9 Jan 2020 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 39368 Active Amended

    Technical documentation EU MDR

    Certifier
    GMED SAS 0459
    Issued
    22 Jul 2026
    Expires
    30 Jul 2028
    Reason
    Other

Timeline

3 dated events

  1. Cleared FDA 510(k) K062366
  2. Listed FDA GUDID 03661522040812
  3. Registered EUDAMED B-03661522040812

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Optime®
Generic name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Device name
Optime
Model / reference
18B15B
Primary DI / UDI-DI
03661522040812
Basic UDI-DI
B-03661522040812, 3661522DTSU1802WW
510(k) Number
FDA product code
GAM
EMDN code
H010101020101, H010101020102
GMDN term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Device class
Class III EUDAMED
Class II GUDID
Regulation number
878.4493
EU registration type
Legacy device (under a directive)
Standard device
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: Polyester suture, bioabsorbable, multifilament, non-antimicrobial

Cleared under the same submission (K062366)

and 8 more cleared under K062366

Similar devices in this category

Other devices filed under POLYGLYCOLIC ACID MULTIFILAMENT WITH NEEDLE FOR OPEN SURGERY.

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)