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FDA 510(k)

OPHTA SIL (R), LACHRYMAL INTUBATION SETS

K-Number: K911109 · 1991-05-01

ApplicantG.W.B. Intl., Ltd.
Decision Date1991-05-01
Product CodeOKS
DecisionSubstantially Equivalent

Device Summary

OPHTA SIL (R), LACHRYMAL INTUBATION SETS 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 1991-05-01 under 510(k) number K911109. The device is classified under product code OKS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTA SIL (R), LACHRYMAL INTUBATION SETS?

OPHTA SIL (R), LACHRYMAL INTUBATION SETS is a medical device that received FDA 510(k) clearance on 1991-05-01. The listed applicant is G.W.B. Intl., Ltd.. The 510(k) number is K911109.

When did OPHTA SIL (R), LACHRYMAL INTUBATION SETS receive FDA 510(k) clearance?

OPHTA SIL (R), LACHRYMAL INTUBATION SETS received FDA 510(k) clearance on 1991-05-01, under 510(k) number K911109.

Who is the listed applicant for OPHTA SIL (R), LACHRYMAL INTUBATION SETS?

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 (R), LACHRYMAL INTUBATION SETS?

The FDA product code for OPHTA SIL (R), LACHRYMAL INTUBATION SETS is OKS.

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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)}K940508OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)K911110OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTSK911108OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS

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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