Covidien Lp, Formerly Registered AS United States: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Covidien Lp, Formerly Registered AS United States” (first 2008, latest 2009), plus 1 PMA decision, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 29 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
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 | 3 | 3 |
| GDW | Staple, Implantable | 2 | 2 |
| OCW | Endoscopic Tissue Approximation Device | 2 | 2 |
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | 1 | 0 |
Review panels
Most recent Covidien Lp, Formerly Registered AS United States 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091869 | SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS | GCJ | 2009-09-01 | 70 |
| K091900 | ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE | GDW | 2009-07-16 | 21 |
| K083519 | AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS | GDW | 2009-04-10 | 135 |
| K090419 | SILS STITCH ENDOSCOPIC SUTURING DEVICE | OCW | 2009-03-09 | 19 |
| K082619 | SILS PORT, MODELS SILSPT5, SILSPT12 | GCJ | 2008-11-07 | 59 |
| K082659 | MODIFIED ENDO STICH | OCW | 2008-09-19 | 7 |
| K081169 | AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR | GCJ | 2008-05-23 | 29 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P010002 | PMA | INDERMIL(TM) TISSUE ADHESIVE | 2002-05-22 |
Recalls
openFDA lists no recalls under a recalling firm named Covidien Lp, Formerly Registered AS United States.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Covidien (224 510(k)s)
- Covidien, Formerly US Surgical A Divison of Tyco H (13 510(k)s)
- Covidien, Formerly Valleylab, A Division of Tyco H (6 510(k)s)
- Covidien, Formerly Nellcor Puritan Bennett, Inc. (5 510(k)s)
- Covidien Lp, Formerly Registered AS Tyco Healthcar (4 510(k)s)
- Covidien Lp, Formerly Registered AS Kendall (3 510(k)s)
- Covidien, LLC( Formerly Beacon Endoscopic Corp.) (2 510(k)s)
- Covidien, LLC, Formerly Registered AS Tyco Healthca (2 510(k)s)
- Covidien Lp, Formerly Know AS Valleylab, A Divison (2 510(k)s)
- Covidien (Part of Medtronic) (2 510(k)s)
- Covidien (Dba Medtronic) (1 510(k)s)
- Covidien, Formerly Valleylab, (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Covidien Lp, Formerly Registered AS United States?
FDA lists 7 510(k) clearances under the applicant name “Covidien Lp, Formerly Registered AS United States” (first 2008, latest 2009), plus 1 PMA decision, across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Covidien Lp, Formerly Registered AS United States?
The median time from FDA receipt to decision across 510(k)s cleared under the name Covidien Lp, Formerly Registered AS United States is 29 days.
Which FDA product codes appear under Covidien Lp, Formerly Registered AS United States?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 3); GDW (Staple, Implantable, 2); OCW (Endoscopic Tissue Approximation Device, 2).
Next steps
- See all 7 Covidien Lp, Formerly Registered AS United States clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Covidien Lp, Formerly Registered AS United States's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.