GOLD SEADS
FDA 510(k) clearance K834027 · decided 1983-12-27
Clearance details
- K-number
- K834027
- Device name
- GOLD SEADS
- Applicant
- Radiation Safety & Nuclear Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-22
- Decision date
- 1983-12-27
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- IWG
- Device class
- 2
- Regulation number
- 892.5730
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 (K081066) | Medi-Physics, Inc., Dba GE Healthcare | 2008-05-05 |
| IMAGYN 125 I SEED, MODEL IS 125 (K982421) | International Isotopes, Inc. | 1998-07-31 |
Recalls involving this device
No recalls on record reference this clearance.