Cleared Traditional

K955671 - RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.) (FDA 510(k) Clearance)

K955671 · G.W.B. Intl., Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
93d
Days
-
Risk

K955671 is an FDA 510(k) clearance for the RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.). Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by G.W.B. Intl., Ltd. (Marshfield, US). The FDA issued a Cleared decision on March 6, 1996 after a review of 93 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.

View all G.W.B. Intl., Ltd. devices

Submission Details

510(k) Number K955671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1995
Decision Date March 06, 1996
Days to Decision 93 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 110d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.