Niic U.S.A., Inc.: FDA clearances and approvals
Niic U.S.A., Inc. has 16 FDA 510(k) clearances (first 1988, latest 1990), across 3 product codes in 2 review panels. Median 510(k) review time: 88 days.
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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 13 | 13 |
| LFL | Instrument, Ultrasonic Surgical | 2 | 2 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 1 | 1 |
Review panels
Most recent Niic U.S.A., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902133 | MODEL IS102S ND:YAG SURGICAL LASER SYSTEM | GEX | 1990-10-02 | 145 |
| K901205 | MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION) | GEX | 1990-08-14 | 153 |
| K902063 | NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM | GEX | 1990-06-29 | 57 |
| K901204 | EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS | GEX | 1990-06-05 | 83 |
| K900185 | NIIC MODEL: DX901 ASPIRATION SYSTEM | JFL | 1990-05-24 | 128 |
| K896988 | NIIC LASER SYSTEM | GEX | 1990-01-23 | 49 |
| K895581 | MODEL: IR205 ARTICULATED SURGICAL LASER | GEX | 1989-12-13 | 89 |
| K895247 | MODEL IR103 SURGICAL LASER SYSTEM | GEX | 1989-11-16 | 87 |
| K895239 | MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER | GEX | 1989-11-16 | 87 |
| K892359 | MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM | GEX | 1989-11-16 | 224 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Niic U.S.A., Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances does Niic U.S.A., Inc. have?
Niic U.S.A., Inc. has 16 FDA 510(k) clearances (first 1988, latest 1990), across 3 product codes in 2 review panels.
How long does FDA take to clear Niic U.S.A., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Niic U.S.A., Inc.'s cleared 510(k)s is 88 days.
What devices does Niic U.S.A., Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 13); LFL (Instrument, Ultrasonic Surgical, 2); JFL (Ph Rate Measurement, Carbon-Dioxide, 1).
Has Niic U.S.A., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Niic U.S.A., Inc. Related entities may recall under other names.
Next steps
- See all 16 Niic U.S.A., Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Niic U.S.A., Inc.'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.