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FDA 510(k)

OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)

K-Number: K940508 · 1994-05-04

ApplicantG.W.B. Intl., Ltd.
Decision Date1994-05-04
Product CodeOKS
DecisionSubstantially Equivalent

Device Summary

OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET) 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 1994-05-04 under 510(k) number K940508. The device is classified under product code OKS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)?

OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET) is a medical device that received FDA 510(k) clearance on 1994-05-04. The listed applicant is G.W.B. Intl., Ltd.. The 510(k) number is K940508.

When did OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET) receive FDA 510(k) clearance?

OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET) received FDA 510(k) clearance on 1994-05-04, under 510(k) number K940508.

Who is the listed applicant for OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)?

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 OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)?

The FDA product code for OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET) 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.

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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.

K955671RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)K954094OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)K950569OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}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.

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