Data / Medical devices / Canada / Glustitch, Inc.
Glustitch, Inc.: FDA-registered device maker in Delta British Columbia, Canada, 4 510(k) clearances
Glustitch, Inc. is registered with the FDA (registration 9615414) in Delta British Columbia, Canada. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 14, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9615414
- FEI number
- 3003769089
- Address
- No. PROGRESS WAY, Delta British Columbia, Canada, V4G 1M6
- Owner or operator
- GLUSTITCH, INC. (9035904)
- Roles
- Manufacturer
- First device listed
- December 3, 2007
- Registered through
- 2027
- Brand names listed
- GluSeal® GLUSEAL(C), GluSeal® GLUSEAL(V), GluSeal® GLUSEAL5(C)HV, GluSeal® GLUSEAL5C, GluSeal® GLUSEAL5V, GluSeal®90 GLUSEAL(ST), GluSeal®90 GLUSEAL(ST)(C), GluSeal®90 GLUSEAL0.5(ST) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid | KMF | 1 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Tissue Adhesive For The Topical Approximation Of Skin | MPN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 14, 2016 | K150032 | GluStitch Twist Tissue Adhesive | MPN | Substantially Equivalent | Glustitch, Inc. | accessdata.fda.gov |
| February 23, 2009 | K083752 | GLUSEAL 90, MODEL GLU9010 | KMF | Substantially Equivalent | Glustitch, Inc. | accessdata.fda.gov |
| October 10, 2007 | K071484 | PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 | EMA | Substantially Equivalent | Glustitch, Inc. | accessdata.fda.gov |
| August 21, 2003 | K030574 | GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER | KMF | Substantially Equivalent | Glustitch, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bandage, Liquid
- All makers of Cement, Dental
- All makers of Tissue Adhesive For The Topical Approximation Of Skin
Updated January 14, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.