Optik: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Optik” (first 1989, latest 1994), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 98 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 |
|---|---|---|---|
| FWF | Camera, Television, Endoscopic, Without Audio | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| HRW | Dynamometer, Nonpowered | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
| JEY | Plate, Bone | 1 | 1 |
| LRZ | Screwdriver, Surgical | 1 | 1 |
Review panels
- General and Plastic Surgery (3)
- Dental (1)
- Neurology (1)
- Orthopedic (1)
Most recent Optik 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933776 | OPTIK LAPAROSCOPE | GCJ | 1994-03-16 | 225 |
| K926166 | COAST VIDEO ENDOSCOPIC IMAGING SYSTEM | FWF | 1993-06-01 | 175 |
| K896404 | TITAMED ANTWERP SYSTEM | JEY | 1990-04-16 | 160 |
| K896589 | MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP | LRZ | 1989-12-27 | 36 |
| K894558 | MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET | HRX | 1989-08-07 | 18 |
| K894557 | LIGHTSCOPE SET | HRW | 1989-08-07 | 18 |
Recalls
openFDA lists no recalls under a recalling firm named Optik.
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 Optik?
FDA lists 6 510(k) clearances under the applicant name “Optik” (first 1989, latest 1994), across 6 product codes in 4 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 Optik?
The median time from FDA receipt to decision across 510(k)s cleared under the name Optik is 98 days.
Which FDA product codes appear under Optik?
The most frequent FDA product codes under this applicant name are FWF (Camera, Television, Endoscopic, Without Audio, 1); GCJ (Laparoscope, General & Plastic Surgery, 1); HRW (Dynamometer, Nonpowered, 1).
Next steps
- See all 6 Optik clearances with predicates and recalls
- Run predicate analysis for product code FWF, Optik'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.