Angiolaz, Inc.: FDA clearances and approvals
Angiolaz, Inc. has 10 FDA 510(k) clearances (first 1990, latest 2000), across 7 product codes in 4 review panels. Median 510(k) review time: 82 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 |
|---|---|---|---|
| FWF | Camera, Television, Endoscopic, Without Audio | 3 | 3 |
| LYK | Angioscope | 2 | 2 |
| FCW | Light Source, Fiberoptic, Routine | 1 | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 | 1 |
| FSR | Light, Headband, Surgical | 1 | 1 |
| FSS | Light, Surgical, Floor Standing | 1 | 1 |
| GCT | Light Source, Endoscope, Xenon Arc | 1 | 1 |
Review panels
Most recent Angiolaz, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994362 | HEADLAMP HL2000. | FSR | 2000-05-11 | 136 |
| K992447 | 50 W METAL HALIDE ILLUMINATOR, VES 0501. | FCW | 1999-10-20 | 90 |
| K982397 | VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM | FWF | 1998-09-10 | 63 |
| K982409 | VES 1501-M | FWF | 1998-08-21 | 42 |
| K981819 | ANGIOLAZ VES-1CAM | FWF | 1998-08-04 | 74 |
| K981821 | VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR | FSS | 1998-07-29 | 68 |
| K981827 | VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM | FET | 1998-07-28 | 67 |
| K933868 | ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES | GCT | 1993-11-10 | 96 |
| K913129 | ANGIOLAZ ANGIOSCOPE CATHETER | LYK | 1991-12-27 | 164 |
| K902329 | ULTRA-VU ANGIOSCOPE | LYK | 1990-08-22 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Angiolaz, 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 Angiolaz, Inc. have?
Angiolaz, Inc. has 10 FDA 510(k) clearances (first 1990, latest 2000), across 7 product codes in 4 review panels.
How long does FDA take to clear Angiolaz, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Angiolaz, Inc.'s cleared 510(k)s is 82 days.
What devices does Angiolaz, Inc. make?
Its most frequent FDA product codes are FWF (Camera, Television, Endoscopic, Without Audio, 3); LYK (Angioscope, 2); FCW (Light Source, Fiberoptic, Routine, 1).
Has Angiolaz, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Angiolaz, Inc. Related entities may recall under other names.
Next steps
- See all 10 Angiolaz, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FWF, Angiolaz, 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.