BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE
FDA 510(k) clearance K875119 · decided 1988-03-02
Clearance details
- K-number
- K875119
- Device name
- BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE
- Applicant
- Advanced Diagnostic Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-15
- Decision date
- 1988-03-02
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- FCI
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Dublin, CA, 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 |
|---|---|---|
| AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING (K895885) | National-Standard Co. | 1990-02-09 |
| BT-338N ELECTRONIC CLINICAL THERMOMETER (K894627) | Integrated Display Technology, Ltd. | 1989-10-23 |
| DISPOSABLE, STERILE BIOPSY PUNCH (K853104) | August C. Stiefel Research Institute, Inc. | 1985-10-04 |
| BIOPSY ATTACHMENT (K831317) | Diasonics, Inc. | 1983-05-18 |
Recalls involving this device
No recalls on record reference this clearance.