CSA Medical
Lexington, MA, US
CSA Medical appears in FDA device records in Lexington, MA. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for CSA Medical between 2007 and 2020. The busiest year on record is 2017, with 4. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 2 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 3 |
| 2016 | 2 |
| 2017 | 4 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201183 | Vortex Radial Spray Catheter | GEH | Substantially Equivalent | |
| K171626 | truFreeze System | GEH | Substantially Equivalent | |
| K172041 | truFreeze System | GEH | Substantially Equivalent | |
| K171522 | truFreeze Rapid AV Spray Kit | GEH | Substantially Equivalent | |
| K163244 | truFreeze System | GEH | Substantially Equivalent | |
| K162695 | truFreeze System | GEH | Substantially Equivalent | |
| K161557 | truFreeze System | GEH | Substantially Equivalent | |
| K152668 | truFreeze System | GEH | Substantially Equivalent | |
| K150920 | truFreeze System | GEH | Substantially Equivalent | |
| K143625 | truFreeze System | GEH | Substantially Equivalent | |
| K133258 | TRUFREEZE SYSTEM | GEH | Substantially Equivalent | |
| K113021 | TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT | GEH | Substantially Equivalent | |
| K072651 | CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM | GEH | Substantially Equivalent | |
| K070893 | CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 | GEH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010140265 | 3010140265 | CSA Medical | 131 Hartwell Ave, Lexington, MA 02421 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1513-2015 | CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01 | TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax | Class II | Terminated | |
| Z-0941-2015 | CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions. | An increase in complaint trending for a loss of audible sound associated with the timer has been observed. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain