Gamp & Assoc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Gamp & Assoc.” (first 1995, latest 1996), across 3 product codes in 1 review panel. 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 |
|---|---|---|---|
| MPA | Endoilluminator | 5 | 5 |
| HQB | Photocoagulator And Accessories | 3 | 3 |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | 1 | 1 |
Review panels
- Ophthalmic (9)
Most recent Gamp & Assoc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952585 | GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR | MPA | 1996-01-05 | 214 |
| K952581 | GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR | MPA | 1996-01-05 | 214 |
| K952569 | GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR | HQR | 1996-01-05 | 214 |
| K954308 | GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE | HQB | 1995-12-22 | 98 |
| K954307 | GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE | HQB | 1995-12-22 | 98 |
| K954306 | GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE | HQB | 1995-12-22 | 98 |
| K952586 | GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR | MPA | 1995-09-01 | 88 |
| K952584 | GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK | MPA | 1995-09-01 | 88 |
| K952580 | GAMP & ASSOCIATES DISPOSABLE BARE END FIBER | MPA | 1995-09-01 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Gamp & Assoc..
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 Gamp & Assoc.?
FDA lists 9 510(k) clearances under the applicant name “Gamp & Assoc.” (first 1995, latest 1996), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gamp & Assoc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gamp & Assoc. is 98 days.
Which FDA product codes appear under Gamp & Assoc.?
The most frequent FDA product codes under this applicant name are MPA (Endoilluminator, 5); HQB (Photocoagulator And Accessories, 3); HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered, 1).
Next steps
- See all 9 Gamp & Assoc. clearances with predicates and recalls
- Run predicate analysis for product code MPA, Gamp & Assoc.'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.