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PDS Absorbable Ligating Clips

by Ethicon Inc.

510(k) K812323

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK812323 Date16 Nov 1981ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0657-05 FDA Unclassified (pre-2012) initiated 28 Feb 2005
    • Terminated Z-0654-05 FDA Unclassified (pre-2012) initiated 28 Feb 2005
    • Terminated Z-0656-05 FDA Unclassified (pre-2012) initiated 28 Feb 2005
    • Terminated Z-0655-05 FDA Unclassified (pre-2012) initiated 28 Feb 2005

    The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
FZP
FDA applicant
ETHICON, Inc.
Device class
Class II
Regulation
21 CFR Part 878.4300
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

PDS Absorbable Ligating Clips are implantable ligating clips designed for use in general and plastic surgery to occlude vessels and tissues by applying mechanical ligation. The clips are constructed from absorbable material that degrades over time, eliminating the need for a second procedure to remove them. They are intended for single-use application in surgical settings where secure tissue approximation is required.

The device is supplied sterile and is intended for single use. It is classified as a Class II medical device under product code FZP and is regulated under the FDA 510(k) premarket notification pathway. The clips are available in multiple sizes to accommodate different tissue diameters and are stored in accordance with manufacturer specifications. The device is not evaluated for MRI compatibility, and its use is limited to the surgical settings specified by the manufacturer.

Other devices from Ethicon Inc.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of PDS Absorbable Ligating Clips?

    These clips are designed to occlude vessels and tissues by applying mechanical ligation during general and plastic surgery procedures. Their absorbable nature means they degrade over time, removing the need for a second surgery to extract them.

  • How are PDS Absorbable Ligating Clips supplied and intended for use?

    The device is supplied sterile and is strictly intended for single-use application. It is classified as a Class II medical device and is regulated under the FDA 510(k) premarket notification pathway, specifically for use in surgical settings requiring secure tissue approximation.

  • Are there any specific storage or compatibility requirements for these clips?

    Storage must adhere to the manufacturer's specifications. Additionally, the device has not been evaluated for MRI compatibility, meaning its safety and functionality in an MRI environment are unknown and it should not be used in patients who are MRI-unsafe.

  • What sizes are available for the PDS Absorbable Ligating Clips?

    The clips are available in multiple sizes to accommodate varying tissue diameters, ensuring that surgeons can select the appropriate clip for the specific anatomical site and tissue thickness encountered during a procedure.