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FDA 510(k)

MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE

K-Number: K883480 · 1988-08-24

ApplicantSite Microsurgical Systems, Inc.
Decision Date1988-08-24
Product CodeFCT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE 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 1988-08-24 under 510(k) number K883480. The device is classified under product code FCT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE?

MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE is a medical device that received FDA 510(k) clearance on 1988-08-24. The listed applicant is Site Microsurgical Systems, Inc.. The 510(k) number is K883480.

When did MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE receive FDA 510(k) clearance?

MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE received FDA 510(k) clearance on 1988-08-24, under 510(k) number K883480.

Who is the listed applicant for MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE?

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 FIBER OPTIC MODULE FOR OPHTHAL. USE?

The FDA product code for MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE is FCT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 30 devices →

Related Devices (Code: FCT)

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.

K960767LIGHT COMMANDERScieran Technologies, Inc.K924198MODIFIED SITE FIBER OPTIC MODULEChiron Vision Corp.K802769FIBER OPTIC HEADLIGHT #60-0765Aspen Laboratories, Inc.K802770FIBER OPTIC HEADLIGHT #60-0766766Aspen Laboratories, Inc.K780433FIBER OPTIC ADJUSTABLE HEADLIGHTCameron-Miller, 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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