Cleared Traditional

K192711 - Dannik Titanium Ligation Clip

K192711 is the FDA 510(k) clearance for Dannik Titanium Ligation Clip by Dannik. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K192711 · Dannik · General & Plastic Surgery device
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Dec 2019
Decision
84d
Days
Class 2
Risk

K192711 is an FDA 510(k) clearance for the Dannik Titanium Ligation Clip. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Dannik (Winter Park, US). The FDA issued a Cleared decision on December 20, 2019 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dannik devices

Submission Details

510(k) Number K192711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2019
Decision Date December 20, 2019
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FZP Clip, Implantable

All 96
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K192711.
InnoClip Disposable Clip Applier, InnoClip Clip Applier
K202994 · Taiwan Surgical Corporation · Jan 2022
Mirus Ligating Clip, Mirus Ligating Clip Applier
K200166 · M/s. Meril Endo Surgery Private Limited. · Nov 2020
Aesculap PAS-Port Proximal Anastomosis System
K202124 · Aesculap, Inc. · Sep 2020
Amsel Endo Occluder
K180650 · Amsel Medical Corporation · Nov 2018
LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier
K181488 · Ethicon Endo-Surgery, LLC · Oct 2018
AnastoClip GC Closure System
K173323 · LeMaitre Vascular, Inc. · Mar 2018