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Weck IPN008501

by Teleflex Incorporated 2 variants

Weck IPN008501 (523100) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K132658 on 27 Nov 2013 and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 14026704417930), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K132658

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 Number14026704417930 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132658 Date27 Nov 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132658 decided 27 Nov 2013 Active
  • FDA GUDID UDI-DI 14026704417930 listed 16 Oct 2015 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1663-2023 FDA Class II initiated 28 Apr 2023

    Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of the clip to the applier. With this step feature missing on the cartridge, the clip is mounted in a more variable position, allowing the clips to load farther back in the clip applier jaw grooves. This may potentially result in inappropriate or inadequate clip application to vascular structures.

Timeline

3 dated events

  1. Cleared FDA 510(k) K132658
  2. Listed FDA GUDID 14026704417930
  3. Recall initiated FDA recalls Z-1663-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Weck
Generic name
Ligation clip, metallic
Model / Ref / Catalog
IPN008501, 523100
Primary DI / UDI-DI
14026704417930
510(k) Number
FDA product code
FZP
GMDN term
Ligation clip, metallic
Device class
Class II
Regulation number
878.4300
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Height — 4.49 Millimeter
Length — 5.79 Millimeter

Related devices

Category: Ligation clip, metallic

Cleared under the same submission (K132658)

and 8 more cleared under K132658

Similar devices in this category

Other devices filed under Ligation clip, metallic.

Other devices from Teleflex Incorporated

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See all devices from Teleflex Incorporated →

Properties

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