D-Clip; D-Clip Applier
FDA 510(k) clearance K180757 · decided 2019-04-12
Clearance details
- K-number
- K180757
- Device name
- D-Clip; D-Clip Applier
- Applicant
- Peter Lazic GmbH
- Decision
- Substantially Equivalent
- Date received
- 2018-03-22
- Decision date
- 2019-04-12
- Days to decision
- 386 days
- Clearance type
- Traditional
- Product code
- HCH
- Device class
- 2
- Regulation number
- 882.5200
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Tuttlingen, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Peter Lazic GmbH
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 |
|---|---|---|
| D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action. recall (Z-1277-2024) | Peter Lazic Gmbh | 2024-03-11 |
| D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action. recall (Z-1278-2024) | Peter Lazic Gmbh | 2024-03-11 |
| D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action. recall (Z-1279-2024) | Peter Lazic Gmbh | 2024-03-11 |