Liquiband Ultima Lut 003
510(k) K100284
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100284 | Date9 Apr 2010 | 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- Withdrawn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
- MPN
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4010
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
Liquiband Ultima Lut 003 is a tissue adhesive for the topical approximation of skin. It is indicated for the closure of topical skin incisions including laparoscopic incisions, and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly cleansed, and have easily approximated edges.
The device is supplied in a single patient use dual tip configuration. It is classified as a Class II medical device under FDA regulation number 878.4010 and received 510(k) clearance (K100284) on April 9, 2010, based on substantial equivalence to a predicate device.
Other devices from Medlogic Global Corp.
Questions
AI-generated answers, 21 Sep 2026
What is LIQUIBAND ULTIMA LUT 003 used for?
LIQUIBAND ULTIMA LUT 003 is indicated for the topical approximation of skin, specifically for closing topical skin incisions such as laparoscopic incisions and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly cleansed, and have easily approximated edges.
How is LIQUIBAND ULTIMA LUT 003 supplied and is it reusable?
The device is supplied in a single patient use dual tip configuration, meaning it is intended for one-time use on one patient and should not be reused due to infection risk and loss of adhesive integrity after application.
What regulatory pathway was used for LIQUIBAND ULTIMA LUT 003 and when was it cleared?
LIQUIBAND ULTIMA LUT 003 received FDA 510(k) clearance (K100284) on April 9, 2010, based on substantial equivalence to a predicate device, and is classified as a Class II medical device under FDA regulation number 878.4010.