Tyco Healthcare Group LP: FDA clearances and approvals
Tyco Healthcare Group LP has 6 FDA 510(k) clearances (first 2001, latest 2008), across 6 product codes in 3 review panels. Median 510(k) review time: 69 days. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.
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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 1 | 1 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 | 1 |
| GDW | Staple, Implantable | 1 | 1 |
| NYU | Catheter, Hemodialysis, Implanted, Coated | 1 | 1 |
Review panels
Most recent Tyco Healthcare Group LP 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080898 | AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT | GDW | 2008-05-05 | 35 |
| K071371 | COPA AMD ANTIMICROBIAL WOUND DRESSING | FRO | 2007-11-19 | 187 |
| K063536 | POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING | GAM | 2007-01-29 | 68 |
| K060509 | PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING | NYU | 2006-06-23 | 116 |
| K060649 | GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000 | FLL | 2006-05-22 | 70 |
| K010909 | NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE | GAW | 2001-04-09 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Tyco Healthcare Group LP.
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.
Device clinical trials
Tyco Healthcare Group LP is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00618787: Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing (Completed, started 2008-02)
- NCT00526123: Dialysis Catheter Comparative Clinical Trial (Completed, started 2007-09)
- NCT00203515: Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley Catheter (Completed, started 2005-01)
Frequently asked questions
How many FDA 510(k) clearances does Tyco Healthcare Group LP have?
Tyco Healthcare Group LP has 6 FDA 510(k) clearances (first 2001, latest 2008), across 6 product codes in 3 review panels.
How long does FDA take to clear Tyco Healthcare Group LP's 510(k)s?
The median time from FDA receipt to decision across Tyco Healthcare Group LP's cleared 510(k)s is 69 days.
What devices does Tyco Healthcare Group LP make?
Its most frequent FDA product codes are FLL (Continuous Measurement Thermometer, 1); FRO (Dressing, Wound, Drug, 1); GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 1).
Has Tyco Healthcare Group LP had device recalls?
openFDA lists no recalls under a recalling firm name matching Tyco Healthcare Group LP. Related entities may recall under other names.
Next steps
- See all 6 Tyco Healthcare Group LP clearances with predicates and recalls
- Run predicate analysis for product code FLL, Tyco Healthcare Group LP'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.