Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)

K-Number: K955671 · 1996-03-06

ApplicantG.W.B. Intl., Ltd.
Decision Date1996-03-06
Product CodeOKS
DecisionSubstantially Equivalent

Device Summary

RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.) is the device name listed in this FDA 510(k) record. The listed applicant is G.W.B. Intl., Ltd.. It received FDA 510(k) clearance on 1996-03-06 under 510(k) number K955671. The device is classified under product code OKS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)?

RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.) is a medical device that received FDA 510(k) clearance on 1996-03-06. The listed applicant is G.W.B. Intl., Ltd.. The 510(k) number is K955671.

When did RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.) receive FDA 510(k) clearance?

RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.) received FDA 510(k) clearance on 1996-03-06, under 510(k) number K955671.

Who is the listed applicant for RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)?

The FDA 510(k) record lists G.W.B. Intl., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)?

The FDA product code for RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.) is OKS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing G.W.B. Intl., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K954094OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)K950569OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}K940508OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)K911110OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTSK911108OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERSK911109OPHTA SIL (R), LACHRYMAL INTUBATION SETS

View all 8 devices →

Related Devices (Code: OKS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201892Ritleng®+ and Ritleng®+ PVPFci (France Chirurgie Instrumentation) SasK201606LacriJet®Fci (France Chirurgie Instrumentation) SasK170247Lacriflow CLKaneka Pharma America, LLCK161373NunchakuFci (France Chirurgie Instrumentation)K160710Oasis Lacrimal Intubation SetAnodyneK130375SELF-RETAINING BICANALICULUS INTUBATON SET IIFci Sas (France Chirurgie Instrumentation)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑