Nds Surgical Imaging: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Nds Surgical Imaging” (first 2008, latest 2022), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 43 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 | 1 | 29 |
| 2013 | 1 | 49 |
| 2014 | 2 | 122 |
| 2015 | 1 | 144 |
| 2016 | 1 | 24 |
| 2017 | 1 | 37 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 26 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nds Surgical Imaging took a median 32 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 6 | 6 |
| LLZ | System, Image Processing, Radiological | 4 | 4 |
Review panels
Most recent Nds Surgical Imaging 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222890 | RADIANCE ULTRA 32 4K ZEROWIRE DUO | GCJ | 2022-10-19 | 26 |
| K170598 | ZeroWire Mobile | GCJ | 2017-04-07 | 37 |
| K161228 | Radiance Ultra Series ZeroWire Embedded | GCJ | 2016-05-26 | 24 |
| K151609 | ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2 | GCJ | 2015-11-06 | 144 |
| K133609 | THE DOME S6C | LLZ | 2014-02-28 | 95 |
| K132770 | DOME S10 | LLZ | 2014-01-30 | 148 |
| K131115 | ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE | GCJ | 2013-06-07 | 49 |
| K120709 | THE DOME GX4MP COLOR NONITOR | LLZ | 2012-04-06 | 29 |
| K100195 | NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X | GCJ | 2010-04-21 | 89 |
| K080320 | PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300 | LLZ | 2008-02-21 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Nds Surgical Imaging.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Nds Surgical Imaging?
FDA lists 10 510(k) clearances under the applicant name “Nds Surgical Imaging” (first 2008, latest 2022), across 2 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 Nds Surgical Imaging?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nds Surgical Imaging is 43 days.
Which FDA product codes appear under Nds Surgical Imaging?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 6); LLZ (System, Image Processing, Radiological, 4).
Next steps
- See all 10 Nds Surgical Imaging clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Nds Surgical Imaging'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.