# Excelsior Leather & Plastic Ind. Co., Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Excelsior Leather & Plastic Ind. Co., Ltd · 89-08 · CHINA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CHINA; product is Smart Swab | Smart Swab; product code is 77 J - - YG Curette, Ear | 77 J - - YT Pick, Microsurgical Ear; date published is 02/10/2017; address is Eastern Industrial , Zone Hung Yip , Zhu Hai City, Guang Dong CHINA, verified against its source on 2026-09-16.

- **Firm:** Excelsior Leather & Plastic Ind. Co., Ltd _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** CHINA _(verified: appears in the quote below)_
- **Address:** Eastern Industrial , Zone Hung Yip , Zhu Hai City, Guang Dong CHINA _(verified: appears in the quote below)_
- **Date published:** 02/10/2017 _(verified: appears in the quote below)_
- **Product code:** 77 J - - YG Curette, Ear | 77 J - - YT Pick, Microsurgical Ear _(verified: each item appears in the quote below)_
- **Product:** Smart Swab | Smart Swab _(verified: each item appears in the quote below)_
- **FDA notes:** Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k). | Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k). _(verified: each item appears in the quote below)_

## What the source says

> Excelsior Leather & Plastic Ind. Co., Ltd Date Published : 02/10/2017 Eastern Industrial , Zone Hung Yip , Zhu Hai City, Guang Dong CHINA 77 J - - YG Curette, Ear Date Published: 02/10/2017 Desc: Smart Swab Notes: Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k). 77 J - - YT Pick, Microsurgical Ear Date Published: 02/10/2017 Desc: Smart Swab Notes: Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k).

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).