MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT
FDA 510(k) clearance K982960 · decided 1998-09-23
Clearance details
- K-number
- K982960
- Device name
- MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT
- Applicant
- Medical Device Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-08-24
- Decision date
- 1998-09-23
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Gainsville, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medical Device Technologies
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 |
|---|---|---|
| BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-0 recall (Z-3192-2024) | Argon Medical Devices, Inc | 2024-09-20 |
| Tru-Core II Disposable Automatic Biopsy Instrument and Tru-Core II URO Disposable Automati recall (Z-0025-2011) | Medical Device Technologies, Inc. | 2010-10-08 |