(313 days)
The Transnasal Lacrimal Stent is indicated in treatments of epiphora treated by dacryocystorhinostomy. Dacryocystorhinostomy (DCR) is the common surgical procedure used to correct nasolacrimal duct obstruction.
Not Found
The provided document is a 510(k) substantial equivalence letter for the Becker Transnasal Lacrimal Stent. It does not contain information about acceptance criteria or specific study details proving device performance. The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval based on substantial equivalence rather than detailed performance study results.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 16 2008
FCI Ophthalmics, Inc. c/o Hillard W. Welch 344 Annabelle Point Rd. Centerville, MA 02632
Re: K023758
Trade/Device Name: Becker Transnasal Lacrimal Stent Regulatory Class: Unclassified Product Code: OKS Dated: November 5, 2002 Received: November 8, 2002
Dear Mr. Welch:
This letter corrects our substantially equivalent letter of September 17, 2003.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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 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 comply with 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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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 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Malvina B. Egleston, ind
Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K023758
Becker Transnasal Lacrimal Stent
, i
Device Name:
Indications for Use:
The Transnasal Lacrimal Stent is indicated in treatments of epiphora treated by dacryocystorhinostomy.
Dacryocystorhinostomy (DCR) is the common surgical procedure used to correct nasolacrimal duct obstruction.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign Off) | |
|---|---|
| Division of Ophthalmic Ear, Nose and Throat Devises | |
| 510(k) Number | K023758 |
| Prescription Use (Per 21 CFR 801.109) | Yes | OR | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | ----- | ---- | ---------------------- |
(Optional Format 1-2-96)
N/A