COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;
FDA 510(k) clearance K050084 · decided 2005-03-17
Clearance details
- K-number
- K050084
- Device name
- COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;
- Applicant
- Cosman Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-01-13
- Decision date
- 2005-03-17
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- GXI
- Device class
- 2
- Regulation number
- 882.4725
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Burlington, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cosman Medical
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 2 recall (Z-2402-2026) | Boston Scientific Neuromodulation Corporation | 2026-06-11 |
| Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.01 recall (Z-2403-2026) | Boston Scientific Neuromodulation Corporation | 2026-06-11 |