Cryomedical Sciences, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Cryomedical Sciences, Inc.” (first 1991, latest 2001), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 130 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 | 9 | 9 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Cryomedical Sciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011073 | CRYOPLAN SYSTEM | GEH | 2001-08-22 | 135 |
| K982055 | ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880 | GEH | 1998-09-08 | 89 |
| K980670 | CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722 | GEH | 1998-07-17 | 147 |
| K980668 | CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790 | GEH | 1998-07-17 | 147 |
| K973190 | ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES | GEI | 1997-11-21 | 88 |
| K970995 | CMS CRYOLITE | GEH | 1997-07-07 | 110 |
| K964336 | CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680 | GEH | 1997-03-20 | 140 |
| K953637 | CMS ACCUPROBE 550/530 | GEH | 1995-12-04 | 124 |
| K952895 | CMS URETHRAL WARMER | GEH | 1995-10-24 | 123 |
| K904421 | CMS ONCOPROBE (TM) | GEH | 1991-04-08 | 193 |
Recalls
openFDA lists no recalls under a recalling firm named Cryomedical Sciences, 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.
- Cryomedical Instruemts , Ltd. (1 510(k)s)
- Cryomedical Instruments, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cryomedical Sciences, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Cryomedical Sciences, Inc.” (first 1991, latest 2001), across 2 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 Cryomedical Sciences, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cryomedical Sciences, Inc. is 130 days.
Which FDA product codes appear under Cryomedical Sciences, Inc.?
The most frequent FDA product codes under this applicant name are GEH (Unit, Cryosurgical, Accessories, 9); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 10 Cryomedical Sciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEH, Cryomedical Sciences, 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.