Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips

K251054 · Teleflex Medical · FZP · Jul 3, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K251054
• Device Name: Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips
• Applicant: Teleflex Medical
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Jul 3, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are intended for use in procedures involving the ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Device Story

Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are single-use, non-active, implantable devices for vessel or tissue ligation. Clips are manufactured from non-absorbable acetal polymer; feature a hinged, bow-shape design with bosses for retention and a locking mechanism. Provided in color-coded, easy-load cartridges. Used by surgeons in general surgical procedures to ligate vessels or tissue structures. The surgeon applies the clip using a compatible applier; the clip must completely encompass the target structure. The device provides permanent ligation, aiding in hemostasis or tissue management. MR safe.

Clinical Evidence

Bench testing only. No clinical data. Performance verified through benchtop testing including clip latching, resistance to leakage, and clip removal after sterilization, environmental conditioning, simulated distribution, and accelerated aging. Biocompatibility assessed per ISO 10993-1, including cytotoxicity, sensitization, reactivity, systemic/subchronic/chronic toxicity, implantation, pyrogenicity, genotoxicity, carcinogenicity, and chemical characterization.

Technological Characteristics

Material: Non-absorbable acetal polymer. Design: Hinged, bow-shape clip with retention bosses and locking mechanism. Cartridge: Color-coded, easy-load with lateral springs. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Biocompatibility: ISO 10993-1 compliant. MR status: MR Safe.

Indications for Use

Indicated for ligation of vessels or tissue structures in general surgical procedures. Contraindicated for fallopian contraceptive tubal occlusion, renal artery ligation during laparoscopic donor nephrectomies, and use with non-compatible ligation systems.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Hem-o-lok™ Ligating Clips (K232970)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 03, 2025

Teleflex Medical
Hope West
Pr. Regulatory Affairs Specialist
3015 Carrington Mill Bld
Morrisville, North Carolina 27560

Re: K251054
Trade/Device Name: Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips
Regulation Number: 21 CFR 878.4300
Regulation Name: Implantable Clip
Regulatory Class: Class II
Product Code: FZP
Dated: April 3, 2025
Received: April 4, 2025

Dear Hope West:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K251054 - Hope West
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K251054 - Hope West
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

TEK N. LAMICHHANE -
S
Tek N. Lamichhane, Ph.D.
Assistant Director
DHT4B: Division of Plastic and
Reconstructive Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K251054 | |
| Device Name Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips | |
| Indications for Use (Describe) The Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are intended for use in procedures involving the ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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510(k) SUMMARY - K251054

# Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips

## A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated
3015 Carrington Mill Blvd
Morrisville, NC 27560 USA
Phone: [phone]
Fax: [phone]

## B. Contact Person

Hope West, RAC-Devices,
Pr. Regulatory Affairs Specialist

## C. Date Prepared

15May2025

## D. Device Name

Trade Name: Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips
Common Name: Implantable Clip
Classification Name: Clip, Implantable
Product Code: FZP, 21 CFR 878.4300

## E. Device Description

Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are single-use, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The clips are manufactured from a non-absorbable acetal polymer and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.

## F. Indications for Use

The Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are intended for use in procedures involving the ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

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G. Contraindications

Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are contraindicated for use as a fallopian contraceptive tubal occlusion device.

Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.

The use of Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips with any other ligation system is contraindicated due to their incompatibility.

H. Environmental Conditions

Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are “MR Safe” and pose no known hazards in MR environments.

I. Substantial Equivalence

The proposed Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are substantially equivalent to the predicate device with respect to technology, intended use, indications and technological characteristics:

| | New Submission | Primary Predicate | Equivalence |
| --- | --- | --- | --- |
| 510(k) Number | K251054 | K232970 | N/A |
| Device Name | Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips | Hem-o-lok™ Ligating Clips | N/A |
| Product Code | FZP | FZP | Identical |
| Regulation | 878.4300 | 878.4300 | Identical |
| Intended Use | Ligation of vessels and tissue structures | | Identical |
| Indications for Use | The Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are intended for use in procedures involving the ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure. | Hem-o-lok™ Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structures to be ligated such that the clip completely encompasses the vessel or tissue structure. | Identical |
| Contraindications | Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are contraindicated for use as a fallopian contraceptive tubal occlusion device.
Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.
The use of Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips with any other ligation system is contraindicated due to their incompatibility. | Hem-o-lok™ Ligating Clips are not intended for use as a fallopian contraceptive tubal occlusion device.
Hem-o-lok™ Ligating Clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies. | Equivalent |

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| | New Submission | Primary Predicate | Equivalence |
| --- | --- | --- | --- |
| Clip Size Offering | Large | Medium, Medium-Large, Large, Extra-Large | Equivalent |
| Clip Material | Acetal Polymer | Acetal Polymer | Identical |
| Clip Design | Hinged, bow-shape clip with bosses for clip retention within the appliers, and a locking mechanism | Hinged, bow-shape clip with bosses for clip retention within the appliers, and a locking mechanism | Equivalent |
| Cartridge Design | Color Coded, Easy Load with lateral springs | Color Coded, Easy Load with lateral springs | Equivalent |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Equivalent |
| Sterilization | Ethylene Oxide (EO); SAL 10^{-6} | Ethylene Oxide (EO); SAL 10^{-6} | Equivalent |

## J. Performance Data

Non-clinical performance testing, consisting of benchtop verification testing for the following has been conducted following product sterilization, environmental conditioning, simulated distribution, and accelerated aging in order to ensure the device performed equivalently to the predicate.

- Clip Latching
- Clip Resistance to Leakage
- Clip Removal

The following biocompatibility endpoints were assessed per ISO 10993-1:

- Cytotoxicity per ISO 10993-5
- Sensitization per ISO 10993-10
- Intracutaneous Reactivity per ISO 10993-10
- Systemic toxicity (acute) per ISO 10993-11
- Subchronic toxicity (subacute) per ISO 10993-11
- Implantation per ISO 10993-6
- Material Mediated Pyrogenicity per ISO 10993-11
- Chronic Toxicity per ISO 10993-11
- Genotoxicity per ISO 10993-3
- Carcinogenicity per ISO 10993-3
- Chemical Characterization per ISO 10993-18

## K. Conclusion

Based upon the performance and comparative test results, the proposed Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clip is substantially equivalent in performance to the predicate device cleared to market via 510(k) K232970. The proposed device does not introduce any new issues of safety and effectiveness.