← Product Code EFQ · K990584 # GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (K990584) _Broadline Medical Industries · EFQ · Apr 23, 1999 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K990584 ## Device Facts - **Applicant:** Broadline Medical Industries - **Product Code:** EFQ - **Decision Date:** Apr 23, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use The intended uses of gauze sponges are absorption of blood and body fluids, wound dressing, prepping and scrubbing, and debridement. This product is patient contacting material. ## Device Story Broadline Gauze Sponges and X-ray Detectable Gauze Sponges are medical-grade sponges used for wound management. They function as absorbent materials for blood and body fluids, wound dressings, and tools for surgical prepping, scrubbing, and debridement. Used in clinical settings by healthcare professionals. X-ray detectable variants include radiopaque elements to allow identification via imaging if retained. These devices provide passive absorption and mechanical assistance during wound care and surgical procedures, aiding in infection control and site preparation. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Gauze sponges; X-ray detectable variants include radiopaque material. Standard absorbent textile construction. Non-sterile or sterile (implied by GMP requirements). ## 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/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle design with three stylized lines representing the eagle's head and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle emblem. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 3 1999 Ms. Anna M. Ramza Quality Assurance Manager Broadline Medical Industries, Inc. 1432 Shire Circle Inverness, Illinois 60067 > K990584 Trade Name: Broadline Gauze Sponges Broadline X-ray Detectable Gauze Sponges Regulatory Class: Unclassified and II Product Code: EFO and GDY Dated: February 19, 1999 Received: February 23, 1999 Dear Ms. Ramza: Re: We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 devices 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1}------------------------------------------------ Page 2 – Ms. Anna M. Ramza This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market. If you desire specific advice for your devices 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) 594-4595. Additionally, for questions on the promotion and advertising of your devices. 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, Colin M. Wittwer, Ph.D., M.D. Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Page_1_of_1 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name:___GAUZE SPONGES:_________________________________________________________________________________________________________________________________________________ Indications For Use: The intended uses of gauze sponges are absorption of blood and body fluids, wound dressing, prepping and scrubbing, and debridement. This product is patient contacting material. .............................................................................................................................................................................. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|--------------------------| | (Division Sign-Off) | | | Division of General Restorative Devices | | | 510(k) Number | K990584 | | Prescription Use | X | | (Per 21 CFR 801.109) | | | | OR | | | Over-The-Counter Use | | | (Optional Format 1-2-96) | ﺗﺘﻌﺪ ﺍ --- **Source:** [https://fda.innolitics.com/device/K990584](https://fda.innolitics.com/device/K990584) **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