Mayaguez Medical Center: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Mayaguez Medical Center” (first 1993, latest 1993), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 114 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 | 6 | 6 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 2 | 2 |
| FGS | Carrier, Sponge, Endoscopic | 1 | 1 |
| KYZ | Syringe, Irrigating (Non Dental) | 1 | 1 |
Review panels
Most recent Mayaguez Medical Center 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932805 | 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT | GCJ | 1993-08-16 | 68 |
| K932804 | IRRIGATING TAPERED PROBE | GCJ | 1993-08-16 | 68 |
| K932806 | POOLE TIP SUCTION PROBE & TUBING KIT | GCJ | 1993-08-11 | 63 |
| K931950 | POOLE TIP SUCTION PROBE | GCY | 1993-08-11 | 113 |
| K931912 | IRRIGATING BLUNT DISSECTOR | KYZ | 1993-08-10 | 116 |
| K931856 | 5.0 MM IRRIGATION/ASPIRATION PROBE | GCY | 1993-08-10 | 119 |
| K931854 | ENDOSCOPIC BLUNT DISSECTING INSTRUMENT | FGS | 1993-08-10 | 119 |
| K931707 | ENDOSCOPIC CABLE/WIRE COVER | GCJ | 1993-08-06 | 122 |
| K931706 | ENDOSCOPIC CABLE DRAPE | GCJ | 1993-08-06 | 122 |
| K931705 | ENDOSCOPIC INSTRUMENT HOLDER | GCJ | 1993-07-22 | 107 |
Recalls
openFDA lists no recalls under a recalling firm named Mayaguez Medical Center.
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 Mayaguez Medical Center?
FDA lists 10 510(k) clearances under the applicant name “Mayaguez Medical Center” (first 1993, latest 1993), across 4 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 Mayaguez Medical Center?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mayaguez Medical Center is 114 days.
Which FDA product codes appear under Mayaguez Medical Center?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 6); GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered, 2); FGS (Carrier, Sponge, Endoscopic, 1).
Next steps
- See all 10 Mayaguez Medical Center clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Mayaguez Medical Center'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.