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Vivosorb 10x13 cm

by Polyganics Innovations B.V.

Vivosorb 10x13 cm (FS01-130/20) is a Class II device made by Polyganics Innovations B.V., cleared under FDA 510(k) K042811 on 8 Nov 2004 and listed in FDA GUDID since 21 Sep 2015 (UDI-DI 08717703990218), 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

510(k) K042811

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08717703990218 UDI-DI Date21 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK042811 Date8 Nov 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K042811 decided 8 Nov 2004 Active
  • FDA GUDID UDI-DI 08717703990218 listed 21 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K042811
  2. Listed FDA GUDID 08717703990218

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vivosorb
Generic name
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Model / Ref / Catalog
10x13 cm, FS01-130/20
Primary DI / UDI-DI
08717703990218
510(k) Number
FDA product code
JXI
GMDN term
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Device class
Class II
Regulation number
882.5275
GUDID distribution status
In Commercial Distribution
Size
Width — 10 Centimeter
Length — 13 Centimeter

Related devices

Category: Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

Cleared under the same submission (K042811)

Similar devices

Other devices filed under FDA product code JXI (Cuff, Nerve).

Other devices from Polyganics Innovations B.V.

  • Neurolac TW 3.0 mm

    Class II

  • NEUROCAP 7.0 mm

    Class II

  • NEUROCAP 2.5 mm

    Class II

  • NEUROCAP 5.0 mm

    Class II

See all devices from Polyganics Innovations B.V. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)