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Deknatel IPN026843

by Teleflex Incorporated

Deknatel IPN026843 (X-4323) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K192490 on 30 Mar 2020 and listed in FDA GUDID since 12 Dec 2017 (UDI-DI 14026704426369), 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) K192490

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192490 Date30 Mar 2020DecidedStatusActive
United StatesGUDID listing Number14026704426369 UDI-DI Date12 Dec 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192490 decided 30 Mar 2020 Active
  • FDA GUDID UDI-DI 14026704426369 listed 12 Dec 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 14026704426369
  2. Cleared FDA 510(k) K192490

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Deknatel
Generic name
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Model / Ref / Catalog
IPN026843, X-4323
Primary DI / UDI-DI
14026704426369
510(k) Number
FDA product code
GAT
GMDN term
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Device class
Class II
Regulation number
878.5000
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Length — 25.9 Millimeter

Related devices

Category: Polyester suture, non-bioabsorbable, multifilament

Cleared under the same submission (K192490)

and 8 more cleared under K192490

Similar devices in this category

Other devices filed under Polyester suture, non-bioabsorbable, multifilament.

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See all devices from Teleflex Incorporated →

Properties

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