Percuvance IPN027870 PCVHCA5: FDA 510(k) K153063

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number14026704582805 UDI-DI	Date16 Nov 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK153063	Date8 Apr 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 14026704582805
FDA 510(k) database 510(k) number K153063

Across registries

2 registries list this device

FDA 510(k) K153063 decided 8 Apr 2016 Active
FDA GUDID UDI-DI 14026704582805 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

19 Jul 2017 Recall initiated FDA recalls Z-3222-2017
19 Jul 2017 Recall initiated FDA recalls Z-3219-2017
19 Jul 2017 Recall initiated FDA recalls Z-3221-2017
19 Jul 2017 Recall initiated FDA recalls Z-3224-2017
19 Jul 2017 Recall initiated FDA recalls Z-3220-2017
19 Jul 2017 Recall initiated FDA recalls Z-3223-2017
18 Oct 2017 Recall initiated FDA recalls Z-0059-2018
16 Nov 2017 Listed FDA GUDID 14026704582805
3 Jan 2018 Recall initiated FDA recalls Z-0754-2019
3 Jan 2018 Recall initiated FDA recalls Z-0753-2019

1 earlier event are in the sections above.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Percuvance
Generic name: Open-surgery ligation clip applier
Model / Ref / Catalog: IPN027870, PCVHCA5

Primary DI / UDI-DI: 14026704582805
510(k) Number: K153063
FDA product code: GEI
GMDN term: Open-surgery ligation clip applier

Device class: Class II
Regulation number: 878.4400
GUDID distribution status: In Commercial Distribution

Size: Width — 0.22 Inch
Length — 2.8 Inch

Category: Open-surgery ligation clip applier

Cleared under the same submission (K153063)

and 4 more cleared under K153063

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Also classified as Open-surgery ligation clip applier.

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Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (9, all answered No)