Niti Medical Technologies , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Niti Medical Technologies , Ltd.” (first 2004, latest 2006), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 57 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| FZP | Clip, Implantable | 5 | 5 |
| GDW | Staple, Implantable | 1 | 1 |
Review panels
Most recent Niti Medical Technologies , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062008 | ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR) | FZP | 2006-08-09 | 23 |
| K050356 | COMPRESSION ANASTOMOSIS RING (CAR) | FZP | 2005-05-05 | 80 |
| K043115 | LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC) | FZP | 2004-12-01 | 21 |
| K042492 | HAND STC, MODEL 60MM | GDW | 2004-10-19 | 35 |
| K041751 | COMPRESSION ANASTOMOSIS CLIP (CAC) | FZP | 2004-09-16 | 79 |
| K033324 | COMPRESSION ANASTOMOSIS CLIP (CAC) | FZP | 2004-05-10 | 208 |
Recalls
openFDA lists no recalls under a recalling firm named Niti Medical Technologies , Ltd..
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.
Device clinical trials
An industry sponsor named Niti Medical Technologies , Ltd. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00497263: End-to-End Compression Anastomosis for Left-sided Colectomy Endo-CAR Study (Completed)
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.
- Niti Surgical Solutions, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Niti Medical Technologies , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Niti Medical Technologies , Ltd.” (first 2004, latest 2006), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Niti Medical Technologies , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Niti Medical Technologies , Ltd. is 57 days.
Which FDA product codes appear under Niti Medical Technologies , Ltd.?
The most frequent FDA product codes under this applicant name are FZP (Clip, Implantable, 5); GDW (Staple, Implantable, 1).
Next steps
- See all 6 Niti Medical Technologies , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FZP, Niti Medical Technologies , Ltd.'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.