Who is the manufacturer of Kerecis Silicone?

Kerecis Limited filed the 510(k) submission for Kerecis Silicone (K213231).

What is the FDA product code for Kerecis Silicone?

KGN. as a Class U device in the SU panel.

What is the regulatory pathway for Kerecis Silicone?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Kerecis Silicone?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Kerecis Silicone

K213231 · Kerecis Limited · KGN · Jun 29, 2022 · SU

Device Facts

Record ID	K213231
Device Name	Kerecis Silicone
Applicant	Kerecis Limited
Product Code	KGN · SU
Decision Date	Jun 29, 2022
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

Kerecis Silicone is indicated for the management of wounds including: - Partial and full-thickness wounds - Pressure ulcers - Venous ulcers - Chronic vascular ulcers - Diabetic ulcers - Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears) - Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) - Draining Wounds

Device Story

Bilayer wound dressing; consists of processed, resorbable, acellular Atlantic Cod fish dermal matrix adhered to thin, transparent, porous, medical-grade silicone layer. Silicone layer provides protection, additional coverage, and adhesive contact to surrounding skin; peelable as fish matrix resorbs. Supplied as sterile sheet. Used in clinical settings for wound management; applied by healthcare professionals. Device acts as scaffold for tissue repair; fish matrix supports cellular ingrowth; silicone facilitates application and protects wound site. Benefits include wound coverage and support for healing process.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included biocompatibility (ISO 10993-5, -10, -11, -6, -3), endotoxin analysis (ANSI/AAMI ST72), tensile strength (ASTM D638-14), hydration, shelf life, and stability. Performance of fish dermal matrix layer leveraged from predicate device data.

Technological Characteristics

Bilayer dressing: resorbable acellular Atlantic Cod fish dermal matrix (approx. 1mm) + porous medical-grade silicone/polyurethane film. Sterile, single-use. Ethylene Oxide sterilization (SAL 10^-6). Mechanical properties tested per ASTM D638-14. No software or electronic components.

Indications for Use

Indicated for management of partial/full-thickness wounds, pressure ulcers, venous/chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), surgical wounds (donor sites/grafts, post-Mohs/laser surgery, podiatric, dehiscence), and draining wounds.

Predicate Devices

Kerecis Marigen Wound Extra (K190528)

Reference Devices

PELNAC™ Bilayer Wound Matrix (K191992)

Related Devices

K182838 — Geistlich Derma-Gide · Geistlich Pharma AG · Nov 8, 2018
K132343 — MARIGEN WOUND DRESSING · Kerecis Limited · Oct 23, 2013
K090823 — THERAFORM BILAYER · Sewon Cellontech Co., Ltd. · Oct 22, 2009
K251845 — Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus · Kerecis Limited · Jul 16, 2025
K250864 — MatriDerm pluS+ Bi-Layer · Medskin Solutions Dr. Suwelack AG · Dec 19, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The words "U.S. FOOD & DRUG" are stacked on top of the word "ADMINISTRATION". June 29, 2022 Kerecis Limited Gudmundur Sigurjonsson President & CEO Eyrargata 2 Isafjordur, 400 Iceland Re: K213231 Trade/Device Name: Kerecis Silicone Regulatory Class: Unclassified Product Code: KGN Dated: September 24, 2021 Received: September 30, 2021 Dear Gudmundur Sigurjonsson: 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 (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 located 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. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213231 Device Name Kerecis Silicone Indications for Use (Describe) Kerecis Silicone is indicated for the management of wounds including: - · Partial and full-thickness wounds - Pressure ulcers - Venous ulcers - · Chronic vascular ulcers - · Diabetic ulcers - · Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears) - · Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) - · Draining Wounds | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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 PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ ## 510(k) SUMMARY - K213231 #### 1. SUBMITTER/510(K) HOLDER Kerecis Limited Eyrargata 2 400 Isafjordur Iceland Contact Person: G. Fertram Sigurjonsson Telephone: 011 354 562 2601 Date Prepared: June 27, 2022 #### 2. DEVICE NAME Proprietary Name: Kerecis Silicone Common/Usual Name: Dressing Wound Collagen Classification Name: Unclassified Product code: KGN #### 3. PREDICATE DEVICES | • | Kerecis Marigen Wound Extra | K190528 | Predicate Device | |---|-----------------------------|---------|------------------| |---|-----------------------------|---------|------------------| - PELNAC™ Bilayer Wound Matrix ● K191992 Reference Device #### 4. DEVICE DESCRIPTION The subject device is a bilayer of processed resorbable acellular fish dermal matrix adhered to a thin, transparent, porous, soft silicone layer. The subject device is obtained from fish skin via standardized controlled GMP manufacturing process. The fish dermal matrix layer is approximately 1 mm in thickness and is porous. The silicone layer is a transparent polyurethane film single-coated with soft, medical grade silicone that is attached to the scaly side of the fish dermal matrix. The silicone layer is porous, soft and conformable to the wound surface. The subject device is supplied as a sterile intact sheet offered in two configurations: a) with the silicone layer extending beyond the borders of the fish dermal matrix and b) the silicone {4}------------------------------------------------ layer having the same dimension as the fish dermal matrix with no silicone layer extending beyond the fish dermal matrix. The silicone acts as: protection for the fish dermal matrix layer, as additional wound coverage, and in configuration (a), as an adhesive contact layer to the skin surrounding the wound. The silicone layer can be peeled off as the fish dermal matrix is resorbed. The device is intended for single use only. #### న. INTENDED USE The subject device is indicated for the management of wounds including: - Partial and full-thickness wounds - Pressure ulcers, ● - Venous ulcers, - Chronic vascular ulcers, ● - Diabetic ulcers, - Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), ● - Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, ● podiatric, wound dehiscence), - Draining wounds ● #### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE The subject device and its predicate, Kerecis Marigen Wound Extra (K190528), are both composed of identical, resorbable, acellular fish skin dermal matrix. The fish skin layer is made from wild-caught Atlantic Cod that is minimally processed in order to preserve the natural proteins and structure of the fish skin. The subject device differs from the predicate device in that it contains a second layer consisting of a porous silicone acts to protect the fish dermal matrix layer and is intended to ease the application of the device. The bilayer configuration of the subject device is similar to the reference device PELNAC Bilayer Wound Matrix (K191992) that includes a silicone layer and a porcine-derived collagen matrix layer. The subject device is substantially equivalent to the predicate device, Kerecis Marigen Wound Extra (K190528). The following table compares the proposed subject device side-by-side with the predicate device, Kerecis Marigen Wound Extra. {5}------------------------------------------------ | Device name | Kerecis Silicone (Subject Device- K213231) | Kerecis Marigen Wound Extra (Primary Predicate- K190528) | Comparison | |--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Manufacturer | Kerecis Limited | Kerecis Limited | N/A | | 510(k) | K213231 | K190528 | N/A | | Intended for prescription and single use only | Yes | Yes | Same | | Product Code | KGN | KGN | Same | | Device ClassificationName | Dressing, Wound, Collagen | Dressing, Wound, Collagen | Same | | Intended use | Kerecis Silicone is intended for the management of wounds including: • Partial and full-thickness wounds • Pressure ulcers • Venous ulcers • Chronic vascular ulcers • Diabetic ulcers • Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears) • Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) • Draining wounds. | Marigen Wound Extra is indicated for the management of wounds including: • Partial and full-thickness wounds • Pressure ulcers • Venous ulcers • Chronic vascular ulcers • Diabetic ulcers • Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) • Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) • Draining wounds | Same | | Materials | Atlantic Cod fish skin + Silicone Film Layer | Atlantic Cod fish skin | Similar | | Shape | Sheet (circular and rectangular) | Sheet (circular and rectangular) | Same | | Supplied sterile? | Yes | Yes | Same | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same | | | SAL 10-6 | SAL 10-6 | | | Intended for single use? | Yes | Yes | Same | | Biocompatibility | Yes | Yes | Same | | Dimensions | Circular (diameter): 15mm fish/25mm silicon 20mm 25mm 30mm 35mm Rectangular: 3x7 cm 7x7 cm 7x10cm 7x20cm | Circular (diameter): 15mm 20mm 25mm 30mm 35mm Rectangular: 3x7 cm 7x7 cm 7x10cm 7x20cm | Same | | Packaging Configuration | Double Terminal Sterile Tyvek®Pouch | Double Terminal Sterile Tyvek® Pouch | Same | | Shelf life | 36 months | 36 Months | Same | ## Summary Table of substantial equivalence {6}------------------------------------------------ #### 7. PERFORMANCE TESTING The following table summarizes the tests that have been performed. The tests are either performed on the fish dermal matrix alone (predicate device, MariGen Wound Extra), or on the subject device. The fish dermal matrix is identical in both devices. {7}------------------------------------------------ | Test | | Standard | |------------------------------------------------------------------------------------------------------------------|------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Cytotoxicity | Pass | ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | | Sensitization | Pass | ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization | | Intracutaneous Irritation | Pass | ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization | | Acute Systemic Toxicity | Pass | ISO 10993-11:2017, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | | Material Mediated Pyrogenicity | Pass | ISO 10993-11:2017, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | | Subacute Systemic Toxicity and Implantation Effects | Pass | ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation and ISO 10993-11:2017, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | | Endotoxin Validation and Analysis | Pass | ANSI/AAMI ST72 Bacterial Endotoxins - Test Methods, Routine Monitoring, And Alternatives To Batch Testing | | Hydration | Pass | N/A | | Shelf Life and Stability | Pass | N/A | | Tensile strength | Pass | ASTM D638-14 Tensile Properties of Plastics | | Additional Performance tests on the Kerecis fish dermal matrix layer alone (leveraged from the predicate device) | | | | Test | | Standard | | Implantation | Pass | ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation | | Genotoxicity | Pass | ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | | Genotoxicity – Chromosomal Aberration | Pass | ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | | Subchronic Toxicity | Pass | ISO 10993-11:2017, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | | Cellular Ingrowth | Pass | N/A | | Cell Remains and Collagen Structure | Pass | N/A | | Hemostatic Properties | Pass | N/A | | Resorption in Sprague-Dawley Rats | Pass | N/A | | Collagen Induced Arthritis Mouse Modal | Pass | N/A | {8}------------------------------------------------ #### 8. CONCLUSION Based on the data provided within this submission, the subject device is substantially equivalent to the predicate device in regard to intended use and indication for use, technological characteristics including principles of operation, performance characteristics and device safety. It is concluded that the subject device is substantially equivalent to the predicate device.