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Percuvance IPN027869

by Teleflex Incorporated

Percuvance IPN027869 (PCVGG5) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K153063 on 8 Apr 2016 and listed in FDA GUDID since 16 Nov 2017 (UDI-DI 14026704582812), active as of 23 Oct 2026. 9 FDA recalls are 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

None ongoing

9 closed

Documents

510(k) K153063

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 Number14026704582812 UDI-DI Date16 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153063 Date8 Apr 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153063 decided 8 Apr 2016 Active
  • FDA GUDID UDI-DI 14026704582812 listed 16 Nov 2017 Listed

Recalls

9 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0754-2019 FDA Class II initiated 3 Jan 2018
    • Terminated Z-0753-2019 FDA Class II initiated 3 Jan 2018

    There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.

    • Terminated Z-0059-2018 FDA Class II initiated 18 Oct 2017

    Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use.

  • 6 recalls, same reason

    • Terminated Z-3222-2017 FDA Class II initiated 19 Jul 2017
    • Terminated Z-3219-2017 FDA Class II initiated 19 Jul 2017
    • Terminated Z-3221-2017 FDA Class II initiated 19 Jul 2017
    • Terminated Z-3224-2017 FDA Class II initiated 19 Jul 2017
    • Terminated Z-3220-2017 FDA Class II initiated 19 Jul 2017
    • Terminated Z-3223-2017 FDA Class II initiated 19 Jul 2017

    For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.

Timeline

11 dated events

  1. Recall initiated FDA recalls Z-3222-2017
  2. Recall initiated FDA recalls Z-3219-2017
  3. Recall initiated FDA recalls Z-3221-2017
  4. Recall initiated FDA recalls Z-3224-2017
  5. Recall initiated FDA recalls Z-3220-2017
  6. Recall initiated FDA recalls Z-3223-2017
  7. Recall initiated FDA recalls Z-0059-2018
  8. Listed FDA GUDID 14026704582812
  9. Recall initiated FDA recalls Z-0754-2019
  10. Recall initiated FDA recalls Z-0753-2019

1 earlier event are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Percuvance
Generic name
Rigid endoscopic tissue manipulation forceps, single-use
Model / Ref / Catalog
IPN027869, PCVGG5
Primary DI / UDI-DI
14026704582812
510(k) Number
FDA product code
GEI
GMDN term
Rigid endoscopic tissue manipulation forceps, single-use
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Size
Width — 0.22 Inch
Length — 3.2 Inch

Related devices

Category: Rigid endoscopic tissue manipulation forceps, single-use

Cleared under the same submission (K153063)

and 4 more cleared under K153063

Other devices from Teleflex Incorporated

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See all devices from Teleflex Incorporated →

Properties

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