D-Clip; D-Clip Applier— 510(k) K180757
Substantially EquivalentPeter Lazic GmbH
FDA 510(k) clearance K180757 for D-Clip; D-Clip Applier, Substantially Equivalent on 2019-04-12. Applicant: Peter Lazic GmbH. Device class: 2.
Clearance details
- Applicant
- Peter Lazic GmbH
- Product code
- Code HCH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5200
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tuttlingen, DE
Recent devices under product code HCH
view all- K211183 — Sugita AVM Microclips
- K131500 — YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS
- K091921 — CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP
- K081640 — GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
- K081489 — L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS
Recalls naming K180757
K-number listed on FDA's recall record- Z-1277-2024 — D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.
- Z-1278-2024 — D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.
- Z-1279-2024 — D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180757.
Data sourced from openFDA. This site is unofficial and independent of the FDA.