Glustitch, Inc.: FDA clearances and approvals
Glustitch, Inc. has 5 FDA 510(k) clearances (first 2001, latest 2016), across 3 product codes in 2 review panels. Median 510(k) review time: 133 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 371 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EMA | Cement, Dental | 2 | 2 |
| KMF | Bandage, Liquid | 2 | 2 |
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | 1 | 1 |
Review panels
Most recent Glustitch, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150032 | GluStitch Twist Tissue Adhesive | MPN | 2016-01-14 | 371 |
| K083752 | GLUSEAL 90, MODEL GLU9010 | KMF | 2009-02-23 | 68 |
| K071484 | PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 | EMA | 2007-10-10 | 133 |
| K030574 | GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER | KMF | 2003-08-21 | 178 |
| K013446 | GLUSITE, MODEL GLU002 | EMA | 2001-12-20 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Glustitch, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Glustitch, Inc. have?
Glustitch, Inc. has 5 FDA 510(k) clearances (first 2001, latest 2016), across 3 product codes in 2 review panels.
How long does FDA take to clear Glustitch, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Glustitch, Inc.'s cleared 510(k)s is 133 days.
What devices does Glustitch, Inc. make?
Its most frequent FDA product codes are EMA (Cement, Dental, 2); KMF (Bandage, Liquid, 2); MPN (Tissue Adhesive For The Topical Approximation Of Skin, 1).
Has Glustitch, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Glustitch, Inc. Related entities may recall under other names.
Next steps
- See all 5 Glustitch, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EMA, Glustitch, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.