MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN-
FDA 510(k) clearance K111529 · decided 2011-07-29
Clearance details
- K-number
- K111529
- Device name
- MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN-
- Applicant
- Insert Molding Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-02
- Decision date
- 2011-07-29
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Cumming, GA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Insert Molding Solutions
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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
No recalls on record reference this clearance.