BIOPSY NEEDLE GUIDE ATTACHMENT
FDA 510(k) clearance K863797 · decided 1987-03-27
Clearance details
- K-number
- K863797
- Device name
- BIOPSY NEEDLE GUIDE ATTACHMENT
- Applicant
- Elscint, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-09-29
- Decision date
- 1987-03-27
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- HGL
- Device class
- 2
- Regulation number
- 884.2960
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Itasca, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GYREX (P840007/S003) | Elscint, Inc. | 1988-04-26 |
| GYREX, MODELS S3500 & S5000 (P840007/S002) | Elscint, Inc. | 1987-10-08 |
| GYREX, MODELS S3500 & S5000 (P840007/S001) | Elscint, Inc. | 1987-04-02 |