← Product Code [EMX](/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX) · K972078 # POST-STOP EPISTAXIS CATHETER (K972078) _Boston Medical Products, Inc. · EMX · Jul 10, 1997 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K972078 ## Device Facts - **Applicant:** Boston Medical Products, Inc. - **Product Code:** [EMX](/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX.md) - **Decision Date:** Jul 10, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4100 - **Device Class:** Class 1 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Intended Use 1. To be used for control of posterior nasal epistaxis. 2. To be used as a inter-surgical posterior nasal packing to help prevent fluid aspiration. ## Device Story Post-Stop™ Epistaxis Catheter is a single-balloon catheter with an integral suction/irrigator lumen; designed for control of posterior intra-nasal hemorrhaging and as inter-operative packing to prevent fluid aspiration. Device includes an internal guide wire to assist placement in the posterior chamber; guide wire is removed post-placement. Balloon is inflated using an included 20cc syringe. Device is used in clinical settings by healthcare professionals to maintain nasal area clarity and prevent catheter clogging via the multi-port suction/irrigator. Benefits include effective hemorrhage control and aspiration prevention during or after surgical procedures. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Constructed of medical grade silicone. Single balloon design with integral multi-port suction/irrigator catheter. Includes internal guide wire and 20cc inflation syringe. Supplied sterile. ## Regulatory Identification An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery. ## Predicate Devices - Product No. 20-10710 (Invotec International, Inc.) ## 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 shows the logo for Boston Medical Products. On the left is a stylized heart shape made of two curved lines. To the right of the heart shape is the text "Boston Medical Products" stacked vertically in a sans-serif font. A horizontal line underlines the text. K972078 SMDA Summary JUL 1 0 1997 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Product: Post-Stop™ Epistaxis Catheter Description: The Post-Stop™ Epistaxis Catheter is a single balloon catheter with integral suction catheter designed for control of posterior intra-nasal hemorrhaging. It can also be used as an inter-operative packing to aid in prevention of fluid aspiration. The balloon is designed to control bleeding in the posterior chamber. The multi-port suction/irrigator catheter can be used to keep the nasal area clear and to help prevent the catheter from clogging. An internal guide wire is included to help direct the catheter into the posterior chamber and is removed after catheter placement. The Post-Stop™ is supplied sterile and includes a 20cc syringe for balloon inflation. ## Indications for Use: 1. To be used for control of posterior nasal epistaxis. 2. To be used as a inter-surgical posterior nasal packing to help prevent fluid aspiration. Predicate Device: Product No. 20-10710 manufactured by Invotec International, Inc., 11243-1 St. John's Industrial Parkway South, Jacksonville, FL 32246. Testing: Device is constructed using well-established medical grade silicone. Submitted by: S. Montgomery, President uart K. Montgomerv. President Date: Boston Medical Products, Inc 117 Flanders Road, Westborough, MA 01581 USA CUSTOMER SERVICE: 1-800-433-BMPI (2674) Tel: 508-898-9300 Fax: 508-898-2373 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is the department's symbol, which consists of a stylized caduceus, a symbol often associated with medicine and healthcare. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Stuart K. Montgomery President Boston Medical Products, Inc. 117 Flanders Road Westborough, MA 01581 Re: K972078 Post-Stop Epistaxis Catheter Dated: May 30 .. 1997. ...... .. Received: June 3, 1997 Regulatory class: I 21 CFR 874.1000/Procode: 77 EMX JUL 10 1997 Dear Mr. Montgomery: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html" Sincerely yours, h. Tliau Yu Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Boston Medical Products, Inc. 117 Flanders Road Westborough, MA 01581 ATT: Stuart K. Montgomery (508) 898-9300 ext. 240 Page 1 of 1 K972018 510(k) Number (if known): Device Name: Indications For Use: 1. To be used for control of posterior nasal epistaxis. 2. To be used as a inter-surgical posterior nasal packing to help prevent fluid aspiration. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Post-Stop™ Epistaxis Catheter Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_ (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Formai 1-2-96) Ra. A. Phillips (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K972078 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K972078](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K972078) **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. 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