Frigitronics of Connecticut, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Frigitronics of Connecticut, Inc.” (first 1976, latest 1989), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 58 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 |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 4 | 4 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 2 | 2 |
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | 1 | 1 |
| HQC | Unit, Phacofragmentation | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Frigitronics of Connecticut, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K891282 | MIC-100 WITH CRYOPROBES | GEH | 1989-06-15 | 98 |
| K872362 | FRIGITRONICS ACC-1000 CAPSULE CUTTER | HQC | 1987-07-27 | 39 |
| K853308 | KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000 | HQE | 1985-10-04 | 58 |
| K834577 | I/A PROBE LINES | — | 1984-05-22 | 145 |
| K840536 | CRYO SURG 5900 | GEH | 1984-04-23 | 75 |
| K834437 | KEATES IRRIGATION/ASPIRATION/VITREOUS | HQE | 1984-03-30 | 102 |
| K822599 | KEATES I/A SYSTEM FRIGITRONICS 4000 | HKP | 1982-10-06 | 40 |
| K811390 | CCS100 CRYOSURGICAL SYSTEM | GEH | 1981-06-16 | 29 |
| K760742 | CS-76 AND/OR CRYOCARE I | GEH | 1976-11-03 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named Frigitronics of Connecticut, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Frigitronics, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Frigitronics of Connecticut, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Frigitronics of Connecticut, Inc.” (first 1976, latest 1989), across 5 product codes in 2 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 Frigitronics of Connecticut, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Frigitronics of Connecticut, Inc. is 58 days.
Which FDA product codes appear under Frigitronics of Connecticut, Inc.?
The most frequent FDA product codes under this applicant name are GEH (Unit, Cryosurgical, Accessories, 4); HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 2); HKP (Instrument, Vitreous Aspiration And Cutting, Battery-Powered, 1).
Next steps
- See all 9 Frigitronics of Connecticut, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEH, Frigitronics of Connecticut, Inc.'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.