Pbn Dilators
by Medical Device Technologies, Inc.
510(k) K990808
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK990808 | Date26 Nov 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FGE
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5010
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Pbn Dilators are a type of Stents, Drains And Dilators For The Biliary Ducts, used in medical procedures. They are designed to facilitate the dilation of biliary ducts. The device is classified as a class 2 device. The Pbn Dilators are used in the field of Gastroenterology and Urology.
The Pbn Dilators are supplied with various registration numbers, including 1123137, 3009121749, and 3009906660. They are regulated under the regulation number 876.5010 and have been cleared by the FDA with the clearance type Traditional and the decision code SESE. The device is associated with the product code FGE and the review advisory committee GU.
Other devices from Medical Device Technologies, Inc.
Questions
AI-generated answers, 23 Sep 2026
What are the PBN Dilators used for?
The PBN Dilators are used to facilitate the dilation of biliary ducts in medical procedures, specifically in the fields of gastroenterology and urology.
How are the PBN Dilators supplied?
The PBN Dilators are supplied with various registration numbers, including 1123137, 3009121749, and 3009906660.
What regulatory classification do the PBN Dilators have?
The PBN Dilators are classified as a class 2 device and are regulated under the regulation number 876.5010.