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FDA 510(k)

SILASTIC SCLERAL SPONGE II W/CIRCLING BD

K-Number: K800140 · 1980-03-03

ApplicantDow Corning Corp. Healthcare Industries Materials
Decision Date1980-03-03
Product CodeHQX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SILASTIC SCLERAL SPONGE II W/CIRCLING BD is the device name listed in this FDA 510(k) record. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. It received FDA 510(k) clearance on 1980-03-03 under 510(k) number K800140. 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 SILASTIC SCLERAL SPONGE II W/CIRCLING BD?

SILASTIC SCLERAL SPONGE II W/CIRCLING BD is a medical device that received FDA 510(k) clearance on 1980-03-03. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. The 510(k) number is K800140.

When did SILASTIC SCLERAL SPONGE II W/CIRCLING BD receive FDA 510(k) clearance?

SILASTIC SCLERAL SPONGE II W/CIRCLING BD received FDA 510(k) clearance on 1980-03-03, under 510(k) number K800140.

Who is the listed applicant for SILASTIC SCLERAL SPONGE II W/CIRCLING BD?

The FDA 510(k) record lists Dow Corning Corp. Healthcare Industries Materials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILASTIC SCLERAL SPONGE II W/CIRCLING BD?

The FDA product code for SILASTIC SCLERAL SPONGE II W/CIRCLING BD is HQX.

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Other records listing Dow Corning Corp. Healthcare Industries Materials 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.

K853186SILASTIC INFLATABLE BONE PLUG H.P.K844637WHITESIDE ACRYLIC CEMENT SPACER SLEEVEK850255DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMETK843995TF-II HIP PROSTHESISK842559WHITESIDE ORTHOLOC TOTAL HIP FEMORALK840357SSA HIP PROSTHESIS

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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.K950599STORS SCLERAL SPONGE II (LINCOFF DESIGN)Storz Ophthalmics, 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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