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FDA 510(k)

MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE

K-Number: K925921 · 1993-12-06

ApplicantSite Microsurgical Systems, Inc.
Decision Date1993-12-06
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Site Microsurgical Systems, Inc.. It received FDA 510(k) clearance on 1993-12-06 under 510(k) number K925921. The device is classified under product code KYG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE?

MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE is a medical device that received FDA 510(k) clearance on 1993-12-06. The listed applicant is Site Microsurgical Systems, Inc.. The 510(k) number is K925921.

When did MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE receive FDA 510(k) clearance?

MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE received FDA 510(k) clearance on 1993-12-06, under 510(k) number K925921.

Who is the listed applicant for MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE?

The FDA 510(k) record lists Site Microsurgical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE?

The FDA product code for MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE is KYG.

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Other records listing Site Microsurgical Systems, 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.

K925828MODIFIED SITE TXR SYSTEMSK931866SITE'S CD II PHACOEMULSIFICATION HANDPIECEK921135IOLAB POWER I.V. POLEK920582180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.K912902PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USEK912739SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE

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Related Devices (Code: KYG)

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.

K010353MED-LOGICS DISPOSABLE ALK TUBINGMed-Logics, Inc.K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025Retinalabs.ComK993591BLADEWORKS DISPOSABLE ALK TUBINGBlade Works, Inc.K981116SOVEREIGN CATARACT EXTRACTION SYSTEMAllergan, Inc.K980647EYE IRRIGATOR MODEL #2020Eye-Deal Ocular Safety Products, Inc.K974561MOISTAIR FLUID AIR TUBING SETAmerican Medical Devices, 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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