← Product Code QSY · K010933 # SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY (K010933) _Alltracel Pharma , Ltd. · QSY · Jan 8, 2002 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K010933 ## Device Facts - **Applicant:** Alltracel Pharma , Ltd. - **Product Code:** QSY - **Decision Date:** Jan 8, 2002 - **Decision:** SESE - **Submission Type:** Abbreviated - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Seal-On™ Topical Hemostatic Spray is intended to be used for topical control of bleeding from minor cuts and abrasions of the skin surface. ## Device Story Seal-On™ is a hemostatic powder spray; contains microdispersed oxidized cellulose in aerosol form. Device applied topically to minor skin cuts/abrasions to control bleeding. Oxidized cellulose acts as absorbable hemostatic agent. Intended for OTC use by patients. Benefits include rapid topical bleeding control for minor wounds. ## Clinical Evidence No clinical data provided; biocompatibility test results included in premarket notification. ## Technological Characteristics Aerosol spray containing microdispersed oxidized cellulose. Plant-derived absorbable hemostatic agent. Minimal systemic absorption. ## Regulatory Identification To temporarily control bleeding and cover external wounds. ## Predicate Devices - Tegagen Alginate Dressing ([K980989](/device/K980989.md)) - Dermaphylyx Calcium Alginate Wound Dressing ([K991608](/device/K991608.md)) - Medtrade Products Alginate Island Dressing ([K000487](/device/K000487.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. June 11, 2023 Alltracel Pharma Ltd. c/o Charles H. Kyper Kyper and Associates 103 Nolen Lane Chapel Hill, North Carolina 27516 Re: K010933 Trade/Device Name: Seal-On™ Topical Hemostatic Powder Spray Regulatory Class: Unclassified Product Code: QSY Dear Charles H. Kyper: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 8, 2002. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov. Sincerely, Julie A. Morabito -S 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 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three horizontal lines representing its wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 0 8 2002 Alltracel Pharma Ltd. c/o Mr. Charles H. Kyper Kyper and Associates 103 Nolen Lane Chapel Hill, North Carolina 27516 Re: K010933/S3 Seal-On™ Hemostatic Powder Spray Regulatory Class: unclassified Product Code: FRO Dated: November 22, 2001 Received: November 26, 2001 Dear Mr. Kyper: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becermined the device is substantially equivalent [(for the indications for use stated in the enclosure)] to legally marketed predicate devices marketed in interstate for associated in the encreations of the enactment date of the Medical Device Amendments or to conniner of the first in 110) 2011 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls and Oosmette He Act. The general controls provisions of the Act include requirements for annual provisions of the Previous and manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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 or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic roll in and ation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. Page 2 - Mr. Charles H. Kyper {2}------------------------------------------------ Page 2 - Mr. Charles H. Kyper This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours. Stypt Rhodes Witten, Ph.D., Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Kol 09 33 ### 3. STATEMENT OF INTENDED USE Seal-On™ Topical Hemostatic Spray is intended to be used for topical control of bleeding from minor cuts and abrasions of the skin surface. NRo for cmis (Division Sign-Off) (Division of C neral, Restorative Division of ical Devices 510(k) Number K010983 {4}------------------------------------------------ K010933 ## 10. 510(k) Summary # JAN 0 8 2002 1. Submitter: Alltracel Pharma Ltd. 10 Church Place Sallynoggin, Co, Dublin Republic of Ireland 2. Contact Person: Dr. Ivan Santar, Scientific Director & QA Officer Phone: 011 353 1 2352162 or 011 420 504 410154 3. Device Name: Seal-On™ Hemostatic Powder Spray 4. Classification Name: Liquid Bandage (21 CFR 880.5090) - 5. Predicate Devices: Tegagen Alginate Dressing (K980989) Dermaphylyx Calcium Alginate Wound Dressing (K991608) Medtrade Products Alginate Island Dressing (K000487) #### 6. Device Description and Intended Use: Seal-On™ is a hemostatic powder spray containing Microdispersed Oxidized Cellulose in an aerosol form and is indicated for OTC use in the topical control of bleeding from minor cuts and abrasions of the skin surface. #### 7. Substantial Equivalence: The intended use of Seal-On™ is consistent with that for the cited predicate devices. It differs from the predicate devices in that its active component is microdispersed oxidized cellulose that, similar to the predicate devices, is derived from a plant source. Oxidized cellulose has very low systemic toxicity and virtually no antigenicity or immunogenicity and has a long history of safe and effective use as an absorbable hemostatic agent during surgical procedures where it is partially or fully absorbed. The intended use of Seal-On™ results in extremely minimal absorption at best. Appropriate biocompatibility test results were included in the premarket notification. --- **Source:** [https://fda.innolitics.com/device/K010933](https://fda.innolitics.com/device/K010933) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com