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FDA 510(k)

RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES

K-Number: K980816 · 1998-09-18

ApplicantFci Ophthalmics, Inc.
Decision Date1998-09-18
Product CodeHQX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES is the device name listed in this FDA 510(k) record. The listed applicant is Fci Ophthalmics, Inc.. It received FDA 510(k) clearance on 1998-09-18 under 510(k) number K980816. The device is classified under product code HQX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES?

RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES is a medical device that received FDA 510(k) clearance on 1998-09-18. The listed applicant is Fci Ophthalmics, Inc.. The 510(k) number is K980816.

When did RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES receive FDA 510(k) clearance?

RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES received FDA 510(k) clearance on 1998-09-18, under 510(k) number K980816.

Who is the listed applicant for RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES?

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

What is the FDA product code for RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES?

The FDA product code for RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES is HQX.

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Other records listing Fci Ophthalmics, 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.

K061404MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICEK061398SNUG PLUG PUNCTUM PLUGK041869SELF RETAINING BICANALICULUS INTUBATION SETK023758BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)K023400FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANTK030054DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES

View all 13 devices →

Related Devices (Code: HQX)

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.

K023481MICROVISION SCLERAL BUCKLING COMPONENTSMicrovision, Inc.K983581OCU-GUARD AND OCU-GUARD SUPPLEBio-Vascular, Inc.K963219RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGESFci Ophthalmics, Inc.K950806SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTSMira, Inc.K950599STORS SCLERAL SPONGE II (LINCOFF DESIGN)Storz Ophthalmics, Inc.K945172VISITEC SILICONE RETINAL IMPLANTS/EXPLANTSVisitec Co.

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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