(27 days)
The Ultraclip II MR intended use is to attach to soft breast tissue at the time of an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called Ultraclip® II MR. It does not contain the detailed study information, acceptance criteria, or performance data of the device.
Therefore, I cannot provide the requested information, which typically would be found in the manufacturer's submission or a separate scientific publication. This letter only confirms that the device has received market clearance based on substantial equivalence to a predicate device.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with three lines forming its body and wings. Above the eagle, the text "HUMAN SERVICES - USA" is arranged in a semi-circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 3 2004
Ms. Melissa Lalomia RA/QA Manager INRAD, Inc. 4375 Donker Ct., S.E. Kentwood, Michigan 49512
Re: K041201
Trade/Device Name: Ultraclip® II MR Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: May 6, 2004 Received: May 7, 2004
Dear Ms. Lalomia:
We have reviewed your Section 510(k) premarket notification of intent to market the indication indication we nave reviewed your becaon 310(x) premaince is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed prodicate devices marketed in interstate for use stated in the encrosure) to regars actment date of the Medical Device Amendments, or to commerce prior to May 26, 1976, the encentions and 1974, in the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). allu Cosmelle Act (71ct) market the device, subject to the general controls provisions of the Act. The You may, ulerclove, market the device, basjon of the manual registration, listing of general controls provisions of the rice, 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 IT your device is classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA Illay be subject to suen additional come in the 21, Parts 800 to 898. In addition, FDA may be found in the Outseenents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be auvised that FDA s issuation of a substitive with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that I DA has made a decerminations administered by other Federal agencies. You must of ally Federal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 807), labeling (21 CFR Part 820), and 820), and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Melissa Lalomia
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premarket notification. The FDA miding of basification 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 Patt 801), please If you desire specific advice for your as (301) 594-4659. Also, please note the regulation entitled, Colliation of Compilance at (Set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gelleral information on your responsed its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincercly 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
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INDICATIONS FOR USE STATEMENT
510K Number if Known:
Device Name:
Ultraclip® II MR
Indications for Use:
The Ultraclip II MR intended use is to attach to soft breast tissue at the THC Ottractip in Mr. an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
iriàm C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K041201
Special 510K Notification
Inrad Inc. Ultraclip® II MR
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Page 17
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.