BIOPSY ATTACHMENT
FDA 510(k) clearance K831317 · decided 1983-05-18
Clearance details
- K-number
- K831317
- Device name
- BIOPSY ATTACHMENT
- Applicant
- Diasonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-22
- Decision date
- 1983-05-18
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- FCI
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- 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 |
|---|---|---|
| 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 |
| BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE (K875119) | Advanced Diagnostic Medical Systems, Inc. | 1988-03-02 |
| DISPOSABLE, STERILE BIOPSY PUNCH (K853104) | August C. Stiefel Research Institute, Inc. | 1985-10-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| DIASONICS NMR IMAGING SYSTEM (P830053/S030) | Diasonics, Inc. | 1988-07-27 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S029) | Diasonics, Inc. | 1988-07-07 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S028) | Diasonics, Inc. | 1988-03-03 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S026) | Diasonics, Inc. | 1987-07-13 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S027) | Diasonics, Inc. | 1987-06-22 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S022) | Diasonics, Inc. | 1987-03-30 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S025) | Diasonics, Inc. | 1987-03-20 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S024) | Diasonics, Inc. | 1987-03-17 |