SIGMA 1 WOBBLER BIOPSY KIT
FDA 510(k) clearance K882673 · decided 1988-07-28
Clearance details
- K-number
- K882673
- Device name
- SIGMA 1 WOBBLER BIOPSY KIT
- Applicant
- Kontron Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-06-28
- Decision date
- 1988-07-28
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- FCH
- Device class
- 1
- Regulation number
- 876.4730
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Everett, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kontron Instruments
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.
| Record | Firm | Date |
|---|---|---|
| MANAN UBK ULTRASONIC GUIDED BIOPSY KIT (K852105) | Manan Manufacturing Co., Inc. | 1985-06-18 |
Recalls involving this device
No recalls on record reference this clearance.