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FDA 510(k)

OCU-GUARD AND OCU-GUARD SUPPLE

K-Number: K983581 · 1998-11-06

ApplicantBio-Vascular, Inc.
Decision Date1998-11-06
Product CodeHQX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OCU-GUARD AND OCU-GUARD SUPPLE is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Vascular, Inc.. It received FDA 510(k) clearance on 1998-11-06 under 510(k) number K983581. 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 OCU-GUARD AND OCU-GUARD SUPPLE?

OCU-GUARD AND OCU-GUARD SUPPLE is a medical device that received FDA 510(k) clearance on 1998-11-06. The listed applicant is Bio-Vascular, Inc.. The 510(k) number is K983581.

When did OCU-GUARD AND OCU-GUARD SUPPLE receive FDA 510(k) clearance?

OCU-GUARD AND OCU-GUARD SUPPLE received FDA 510(k) clearance on 1998-11-06, under 510(k) number K983581.

Who is the listed applicant for OCU-GUARD AND OCU-GUARD SUPPLE?

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

What is the FDA product code for OCU-GUARD AND OCU-GUARD SUPPLE?

The FDA product code for OCU-GUARD AND OCU-GUARD SUPPLE is HQX.

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Other records listing Bio-Vascular, 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.

K002233BVI SLINGK992537PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATEDK983602CV PERI-GUARD AND VASCU-GUARDK983162PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASCK981624FLO-THRUK982282DURA-GUARD - DURAL REPAIR PATCH

View all 26 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.K980816RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGESFci Ophthalmics, 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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