← Product Code [NEU](/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU) · K042341 # ULTRACLIP II US (K042341) _Inrad · NEU · Sep 20, 2004 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K042341 ## Device Facts - **Applicant:** Inrad - **Product Code:** [NEU](/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU.md) - **Decision Date:** Sep 20, 2004 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 878.4300 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use The Ultraclip II US intended use is to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy procedure. ## Device Story Ultraclip II US is an implantable clip designed for marking soft breast tissue at a biopsy site. Used during open surgical or percutaneous breast biopsy procedures. Device provides a permanent marker for the surgical site to assist clinicians in future localization or follow-up. Operated by physicians (surgeons/radiologists) in clinical settings. No complex electronics or software; purely mechanical implantable device. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Implantable clip for soft tissue marking. Mechanical design. Materials and specifications not detailed in provided text. Non-electronic, non-software device. ## Regulatory Identification An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable. ## 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 logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and health. The caduceus is composed of three parallel lines that curve and intersect to form a wing-like shape. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 0 2004 Ms. Melissa Lalomia RA/QA Manager Inrad, Inc. 4375 Donker Court, S.E. Kentwood, Michigan 49512 Re: K042341 Trade/Device Name: Ultraclip® II US Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU, GDW Dated: August 25, 2004 Received: August 30, 2004 Dear Ms. Lalomia: We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 210(x) premained insubstantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regard manation provide Americal Device American be of to commerce print to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appen o the general controls provisions of the Act. The You may, merciole, market the act include requirements for annual registration, listing of general controls provisions of the 1100 libeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 a0070) also existing major regulations affecting your device can may be subject to such additional controls. Existing major and division FD may be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may be found in the OOG neements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri b iboadires or our device complies with other requirements of the Act that I DA has made a acternmalations administered by other Federal agencies. You must of any Federal Statures and regulations daminders but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fatt 807), labeling (21 OFR Part 820); and if applicable, the electronic 10thi in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Page 2 - Ms. Melissa Lalomia This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin manical equivalence of your device of your device to a legally premarket notification: "The PDA mining of casion 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), please If you desire specific advice for your do rice of other notes note the regulation entitled, and Colliact the Office of Compularse in (est notification" (21CFR Part 807.97). You may obtain Misolanung by telefone to premainto no international the Act from the Division of Small other general intonnational on your response at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Miriam C. Provost Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT K042341 510K Number if Known: Device Name: Ultraclip® II US Indications for Use: The Ultraclip II US intended use is to attach to soft breast tissue at the The Ultractip II US Intended use is "It unash books" a percutaneous breast surgical site during an open surgical breast biopsy or a percutaneous breast surgical site dunny an open Surgiour bread. Instruction of the biopsy procedure. Prescription Use × (Per 21 CFR 801.109) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Concurrence of CDRH, Office of Device Evaluation (ODE) Miriam C. Provost (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** K042341 Special 510K Notification Inrad Inc. Ultraclip® II US Page 18 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K042341](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K042341) **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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