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FDA 510(k)

SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE

K-Number: K862943 · 1986-08-21

ApplicantSite Microsurgical Systems, Inc.
Decision Date1986-08-21
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE 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 1986-08-21 under 510(k) number K862943. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE?

SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE is a medical device that received FDA 510(k) clearance on 1986-08-21. The listed applicant is Site Microsurgical Systems, Inc.. The 510(k) number is K862943.

When did SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE receive FDA 510(k) clearance?

SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE received FDA 510(k) clearance on 1986-08-21, under 510(k) number K862943.

Who is the listed applicant for SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE?

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 SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE?

The FDA product code for SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE is HQE.

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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 SYSTEMSK925921MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTEK931866SITE'S CD II PHACOEMULSIFICATION HANDPIECEK921135IOLAB POWER I.V. POLEK920582180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.K912902PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE

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Related Devices (Code: HQE)

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.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, 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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