# K150032: GluStitch Twist Tissue Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Glustitch, Inc.
- Decided: Jan 14, 2016 after 371 days
- Product code: MPN (Tissue Adhesive For The Topical Approximation Of Skin)
- Device class: 2
- Regulation: 21 CFR 878.4010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P010002 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P010002: Indermil (TM) Tissue Adhesive, Covidien Lp, Formerly Registered AS United States (2002) Summary page 4.

## Indications for use
GluStitch® Twist Tissue Adhesive is intended for the topical closure of surgical skin incisions and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly-cleansed, and have easily approximated skin edges. GluStitch® Twist may be used in conjunction with, but not in place of, deep dermal stitches.

Source page: https://510kreport.com/device/K150032
Methodology: https://510kreport.com/methodology