Taut, Inc.: FDA clearances and approvals
Taut, Inc. has 16 FDA 510(k) clearances (first 1983, latest 2002), across 8 product codes in 4 review panels. Median 510(k) review time: 75 days. openFDA lists 1 product recall by a recalling firm named Taut, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 5 | 5 |
| GBW | Catheter, Peritoneal | 3 | 3 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 | 2 |
| GBX | Catheter, Irrigation | 1 | 1 |
| GBZ | Catheter, Cholangiography | 1 | 1 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
Review panels
- General and Plastic Surgery (10)
- General Hospital (4)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent Taut, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023261 | ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244 | GCJ | 2002-12-13 | 74 |
| K021731 | ADAPT OPEN ACCESS PORT, MODEL 41233 | GCJ | 2002-08-08 | 76 |
| K011018 | TAUT BALLOON CATHETER, MODEL 50640 | GCA | 2001-06-22 | 79 |
| K010007 | ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP | GCJ | 2001-02-22 | 51 |
| K003703 | TAUT-INSUFFLATION NEEDLE | HIF | 2001-02-22 | 83 |
| K992907 | INTRADUCER | GBW | 1999-10-05 | 36 |
| K992904 | MINI-PORT | GBW | 1999-10-05 | 36 |
| K972112 | INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 | GBW | 1997-12-01 | 179 |
| K962003 | TUAT SPLATTER CONTROL SHIELD SCS-300 | KKX | 1996-07-18 | 57 |
| K960883 | INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8 | GCJ | 1996-03-20 | 15 |
6 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-01-19.
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 Taut, Inc. have?
Taut, Inc. has 16 FDA 510(k) clearances (first 1983, latest 2002), across 8 product codes in 4 review panels.
How long does FDA take to clear Taut, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Taut, Inc.'s cleared 510(k)s is 75 days.
What devices does Taut, Inc. make?
Its most frequent FDA product codes are GCJ (Laparoscope, General & Plastic Surgery, 5); GBW (Catheter, Peritoneal, 3); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 2).
Has Taut, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Taut, Inc; the most recent began 2007-01-19. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 16 Taut, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Taut, 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.