Del Medical Systems Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Del Medical Systems Corp.” (first 1994, latest 1996), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 97 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 5 | 5 |
| DZA | Drill, Dental, Intraoral | 1 | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 | 1 |
Review panels
Most recent Del Medical Systems Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962684 | S-357 VIDEO IMAGING SYSTEM | GCJ | 1996-10-15 | 97 |
| K962651 | S-52 ELECTRONIC VIDEO LAPAROSCOPE | GCJ | 1996-09-30 | 84 |
| K960301 | ND VISION-220 ADAPTIVE IMAGE PROCESSESSOR | GCJ | 1996-09-30 | 252 |
| K962979 | S-53 INTRORAL DENTAL SYSTEM | DZA | 1996-09-25 | 56 |
| K962020 | S-41 & S-41S VIDEO IMAGING SYSTEM | GCJ | 1996-08-30 | 99 |
| K962024 | S-57 VIDEO IMAGING SYSTEM | FET | 1996-07-09 | 47 |
| K942924 | MSV-2000 VIDEO IMAGING SYSTEM | GCJ | 1994-10-03 | 103 |
Recalls
openFDA lists no recalls under a recalling firm named Del Medical Systems Corp..
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 Del Medical Systems Corp.?
FDA lists 7 510(k) clearances under the applicant name “Del Medical Systems Corp.” (first 1994, latest 1996), across 3 product codes in 3 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 Del Medical Systems Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Del Medical Systems Corp. is 97 days.
Which FDA product codes appear under Del Medical Systems Corp.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 5); DZA (Drill, Dental, Intraoral, 1); FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology, 1).
Next steps
- See all 7 Del Medical Systems Corp. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Del Medical Systems Corp.'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.