Cleared Traditional

K121142 - CRAWFORD BIOCANALICULUS INTUBATION

K121142 · Fci Sas (France Chirurgie Instrumentation) · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
115d
Days
-
Risk

K121142 is an FDA 510(k) clearance for the CRAWFORD BIOCANALICULUS INTUBATION. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Fci Sas (France Chirurgie Instrumentation) (Cincinnati, US). The FDA issued a Cleared decision on August 9, 2012 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K121142

510(k) Number K121142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2012
Decision Date August 09, 2012
Days to Decision 115 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 110d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

OKS Device Classification - Class 0,

Product Code OKS Lacrimal Stents And Intubation Sets
Device Class -
Definition Lacrimal Stents And Intubations Sets Are Intended To Repair The Lacrimal Drainage System. Lacrimal Stents And Intubations Sets Are Indicated For, But Limited To, The Treatment Of Epiphora In Infants And Adults; Canalicular Pathologies Such As Stenosis; Obstruction Or Laceration; And Conditions Requiring Dacryocystorhinostomy (conventional Or Laser); Or Imperforation Of The Nasolacrimal Duct In An Infant.

Regulatory Peers - OKS Lacrimal Stents And Intubation Sets

All 29
Devices cleared under the same product code (OKS) and FDA review panel - the closest regulatory comparables to K121142.
DCS LACRIMAL STENT
K113316 · Dcs Surgical, Inc. · Nov 2012
LACRICATH LACRIMAL DUCT CATHETER
K113867 · Quest Medical, Inc. · Oct 2012
DACRYOCATH
K113508 · Armadillo Biomedical, LLC · Aug 2012
MASTERKA 40 MASTERKA 35 MASTERKA 30
K113536 · Fci Sas (France Chirurgie Instrumentation) · Aug 2012
STENTUBE LACRIMAL INTUBATION SET
K113118 · Quest Medical, Inc. · Jul 2012
MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE
K061404 · Fci Ophthalmics, Inc. · Aug 2006
K121142 · CRAWFORD BIOCANALICULUS INTUBATION
Download PDF FDA Summary Fci Sas (France Chiru…