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FDA 510(k)

ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG

K-Number: K880953 · 1988-05-13

ApplicantAdvanced Surgical Products, Inc.
Decision Date1988-05-13
Product CodeLXP
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Surgical Products, Inc.. It received FDA 510(k) clearance on 1988-05-13 under 510(k) number K880953. 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 ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG?

ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG is a medical device that received FDA 510(k) clearance on 1988-05-13. The listed applicant is Advanced Surgical Products, Inc.. The 510(k) number is K880953.

When did ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG receive FDA 510(k) clearance?

ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG received FDA 510(k) clearance on 1988-05-13, under 510(k) number K880953.

Who is the listed applicant for ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG?

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

What is the FDA product code for ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG?

The FDA product code for ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG is LXP.

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Other records listing Advanced 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.

K030926FAST THROW STAINLESS STEEL SURGICAL SUTUREK895800ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATORK896754I/A HANDPIECEK896305MULTI-USE I/A HANDPIECEK884557ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECEK884556DREYER CURVED ENDOILLUMINATOR

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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.K871604MVS 19 AND MVS 20 GAUGE SCLERAL PLUGSAdvanced 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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