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FDA 510(k)

DISPOSABLE SCLERAL GLOBE PLUG

K-Number: K840693 · 1984-05-22

ApplicantInnovative Surgical Products, Inc.
Decision Date1984-05-22
Product CodeLXP
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SCLERAL GLOBE PLUG is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Surgical Products, Inc.. It received FDA 510(k) clearance on 1984-05-22 under 510(k) number K840693. The device is classified under product code LXP. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE SCLERAL GLOBE PLUG?

DISPOSABLE SCLERAL GLOBE PLUG is a medical device that received FDA 510(k) clearance on 1984-05-22. The listed applicant is Innovative Surgical Products, Inc.. The 510(k) number is K840693.

When did DISPOSABLE SCLERAL GLOBE PLUG receive FDA 510(k) clearance?

DISPOSABLE SCLERAL GLOBE PLUG received FDA 510(k) clearance on 1984-05-22, under 510(k) number K840693.

Who is the listed applicant for DISPOSABLE SCLERAL GLOBE PLUG?

The FDA 510(k) record lists Innovative Surgical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE SCLERAL GLOBE PLUG?

The FDA product code for DISPOSABLE SCLERAL GLOBE PLUG is LXP.

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Other records listing Innovative Surgical Products, Inc. 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.

K843041HESLIN DISPOS. TUBING SETK840695PHACOEMULSIFICATION KITSK840694LENS INSERTION GLIDEK841072IRRIGATION, ASPIRATION TUBING SETSK832235DISPOSABLE VITRECTOMY HANDPIECEK821496DISPOSABLE IRRIGA/ASPIR. SYSTEM

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Related Devices (Code: LXP)

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.

K022186SCLERAL PLUGS, 19 AND 20 GAUGEMicrovision, Inc.K990872SCLERAL PLUGS, 19 AND 20 GAUGEOphthalmic Consultants, Inc.K945114VISITEC SCLERAL PLUGVisitec Co.K925671DISPOSABLE SCLERAL PLUGSO.R. Specialties, Inc.K880952PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGSAdvanced Surgical Products, Inc.K880953ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUGAdvanced Surgical Products, 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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