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FDA 510(k)

STORS SCLERAL SPONGE II (LINCOFF DESIGN)

K-Number: K950599 · 1995-03-02

ApplicantStorz Ophthalmics, Inc.
Decision Date1995-03-02
Product CodeHQX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STORS SCLERAL SPONGE II (LINCOFF DESIGN) is the device name listed in this FDA 510(k) record. The listed applicant is Storz Ophthalmics, Inc.. It received FDA 510(k) clearance on 1995-03-02 under 510(k) number K950599. 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 STORS SCLERAL SPONGE II (LINCOFF DESIGN)?

STORS SCLERAL SPONGE II (LINCOFF DESIGN) is a medical device that received FDA 510(k) clearance on 1995-03-02. The listed applicant is Storz Ophthalmics, Inc.. The 510(k) number is K950599.

When did STORS SCLERAL SPONGE II (LINCOFF DESIGN) receive FDA 510(k) clearance?

STORS SCLERAL SPONGE II (LINCOFF DESIGN) received FDA 510(k) clearance on 1995-03-02, under 510(k) number K950599.

Who is the listed applicant for STORS SCLERAL SPONGE II (LINCOFF DESIGN)?

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

What is the FDA product code for STORS SCLERAL SPONGE II (LINCOFF DESIGN)?

The FDA product code for STORS SCLERAL SPONGE II (LINCOFF DESIGN) is HQX.

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Other records listing Storz 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.

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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.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.K945172VISITEC SILICONE RETINAL IMPLANTS/EXPLANTSVisitec Co.

Official Source

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