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FDA 510(k)

OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS

K-Number: K911108 · 1991-05-13

ApplicantG.W.B. Intl., Ltd.
Decision Date1991-05-13
Product CodeLZU
DecisionSubstantially Equivalent

Device Summary

OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS 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 1991-05-13 under 510(k) number K911108. The device is classified under product code LZU. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS?

OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS is a medical device that received FDA 510(k) clearance on 1991-05-13. The listed applicant is G.W.B. Intl., Ltd.. The 510(k) number is K911108.

When did OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS receive FDA 510(k) clearance?

OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS received FDA 510(k) clearance on 1991-05-13, under 510(k) number K911108.

Who is the listed applicant for OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS?

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), PUNCTAL PLUGS AND INSERTERS?

The FDA product code for OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS is LZU.

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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 IMPLANTSK911109OPHTA SIL (R), LACHRYMAL INTUBATION SETS

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Related Devices (Code: LZU)

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.

K241229Hello,eyes® BIO PlugBio Optics Co., Ltd.K222164Visant Medical Canalicular PlugVisant Medical, Inc.K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis Medical, Inc.K190210Tear Pool Dissolvable Punctum PlugsAlphamed, Inc.K162361Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc.K161673LacriPro Punctum PlugLacrimedics, Inc.

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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