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FDA 510(k)

SCLERAL PLUG

K-Number: K831193 · 1983-06-30

ApplicantMedical Instrument Development Laboratories, Inc.
Decision Date1983-06-30
Product CodeLXP
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SCLERAL PLUG is the device name listed in this FDA 510(k) record. The listed applicant is Medical Instrument Development Laboratories, Inc.. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K831193. 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 SCLERAL PLUG?

SCLERAL PLUG is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Medical Instrument Development Laboratories, Inc.. The 510(k) number is K831193.

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

SCLERAL PLUG received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831193.

Who is the listed applicant for SCLERAL PLUG?

The FDA 510(k) record lists Medical Instrument Development Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCLERAL PLUG?

The FDA product code for SCLERAL PLUG is LXP.

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Other records listing Medical Instrument Development Laboratories, 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.

K102222ULTIMATE VIT ENHAMCER (UVE)K020911MID LABS AUTONOMOUS VIT ENHANCER (AVE)K992943VIT ENHANCERK971067DIGI-INJECTORK950287UNIVIT PROBEK934600MICRODRIVE

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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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