# Smie Srl · 89-08 · ITALY — FDA import alert red lists: firms subject to detention without physical examination

For Smie Srl · 89-08 · ITALY, 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 ITALY; product code is 85 M - - GI Aspirator, Ultrasonic; date published is 09/16/2009; address is Via Francesco Negri 15 , Casale Monferrato, Alexandria ITALY, verified against its source on 2026-09-16.

- **Firm:** Smie Srl _(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:** ITALY _(verified: appears in the quote below)_
- **Address:** Via Francesco Negri 15 , Casale Monferrato, Alexandria ITALY _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 85 M - - GI Aspirator, Ultrasonic _(verified: appears in the quote below)_
- **FDA notes:** Sculpture Ultrasonic Aspiration Device (Sculture Ultrasound Wave Liposculpture) 1/22/1999 _(verified: appears in the quote below)_

## What the source says

> Smie Srl Date Published : 09/16/2009 Via Francesco Negri 15 , Casale Monferrato, Alexandria ITALY 85 M - - GI Aspirator, Ultrasonic Date Published: 09/16/2009 Notes: Sculpture Ultrasonic Aspiration Device (Sculture Ultrasound Wave Liposculpture) 1/22/1999

## 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/).