United States Surgical, A Division of Tyco Healthc: FDA filings under this applicant name
FDA lists 218 510(k) clearances under the applicant name “United States Surgical, A Division of Tyco Healthc” (first 1977, latest 2007), across 67 product codes in 9 review panels. Median 510(k) review time under this name: 70 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 | 30 | 30 |
| GDW | Staple, Implantable | 28 | 28 |
| FZP | Clip, Implantable | 17 | 17 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 12 | 12 |
| HET | Laparoscope, Gynecologic (And Accessories) | 9 | 9 |
| HAO | Instrument, Surgical, Non-Powered | 7 | 7 |
| FTL | Mesh, Surgical, Polymeric | 5 | 5 |
| GAP | Suture, Nonabsorbable, Silk | 5 | 5 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 | 5 |
| HRX | Arthroscope | 5 | 5 |
Plus 57 more product codes.
Review panels
- General and Plastic Surgery (147)
- Orthopedic (25)
- Obstetrics and Gynecology (13)
- Neurology (9)
- General Hospital (8)
- Ear, Nose and Throat (5)
- Gastroenterology and Urology (5)
- Cardiovascular (4)
- Hematology (1)
Most recent United States Surgical, A Division of Tyco Healthc 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071406 | AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER | FZP | 2007-11-21 | 184 |
| K071920 | AUTOSUTURE ABSORBABLE TACK AND APPLICATOR | GDW | 2007-09-28 | 78 |
| K061288 | AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER | FZP | 2006-11-02 | 177 |
| K062850 | AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS | GDW | 2006-10-23 | 28 |
| K062326 | AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE | GCJ | 2006-09-01 | 23 |
| K061095 | AUTO SUTUR ENDO GIA STAPLERS | GDW | 2006-05-31 | 42 |
| K050947 | MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE | GAW | 2005-06-01 | 47 |
| K042412 | MODIFIED SPACEMAKER SYSTEM | GCJ | 2004-09-24 | 17 |
| K040594 | HERCULON SOFT TISSUE REATTACHMENT SYSTEM | HWC | 2004-03-31 | 23 |
| K032696 | AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT | GDW | 2003-12-01 | 90 |
208 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named United States Surgical, A Division of Tyco Healthc.
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.
- United States Endoscopy Group, Inc. (94 510(k)s)
- United Orthopedic Corporation (61 510(k)s)
- United Biotech, Inc. (22 510(k)s)
- United Consortium (15 510(k)s)
- United Diagnostics, Inc. (12 510(k)s)
- United Medical Industries Co. , Ltd. (10 510(k)s)
- United Surgical Corp. (7 510(k)s)
- United Pacific Co., Ltd. (6 510(k)s)
- United Dental Mfg., Inc. (5 510(k)s)
- United Medical Systems, Inc. (5 510(k)s)
- United Sonics, Inc. (5 510(k)s)
- United Medical (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under United States Surgical, A Division of Tyco Healthc?
FDA lists 218 510(k) clearances under the applicant name “United States Surgical, A Division of Tyco Healthc” (first 1977, latest 2007), across 67 product codes in 9 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 United States Surgical, A Division of Tyco Healthc?
The median time from FDA receipt to decision across 510(k)s cleared under the name United States Surgical, A Division of Tyco Healthc is 70 days.
Which FDA product codes appear under United States Surgical, A Division of Tyco Healthc?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 30); GDW (Staple, Implantable, 28); FZP (Clip, Implantable, 17).
Next steps
- See all 218 United States Surgical, A Division of Tyco Healthc clearances with predicates and recalls
- Run predicate analysis for product code GCJ, United States Surgical, A Division of Tyco Healthc'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.