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FDA 510(k)

SILICONE SPHERES

K-Number: K112176 · 2011-09-15

ApplicantOculo Plastik, Inc.
Decision Date2011-09-15
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SILICONE SPHERES is the device name listed in this FDA 510(k) record. The listed applicant is Oculo Plastik, Inc.. It received FDA 510(k) clearance on 2011-09-15 under 510(k) number K112176. The device is classified under product code HPZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE SPHERES?

SILICONE SPHERES is a medical device that received FDA 510(k) clearance on 2011-09-15. The listed applicant is Oculo Plastik, Inc.. The 510(k) number is K112176.

When did SILICONE SPHERES receive FDA 510(k) clearance?

SILICONE SPHERES received FDA 510(k) clearance on 2011-09-15, under 510(k) number K112176.

Who is the listed applicant for SILICONE SPHERES?

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

What is the FDA product code for SILICONE SPHERES?

The FDA product code for SILICONE SPHERES is HPZ.

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Other records listing Oculo Plastik, 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.

K123764DURETTE OCULAR IMPLANTK073293DURETTE IMPLANTK040689EYE SPHERE IMPLANTSK934834EPTFE SHEET COVERING FOR OCULAR IMPLANTK915630OPHTIMPLANTK901002O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES

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Related Devices (Code: HPZ)

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.

K212741EZYPORFci (France Chirurgie Instrumentation) SasK123764DURETTE OCULAR IMPLANTOculo-Plastik, Inc.K110554BIOCERAMIC ORBITAL IMPLANT, ORBTEXCeramisys, Ltd.K083342ORBITAL RECONSTRUCTIVE IMPLANT IIEvera Medical, Inc.K082850EYE SPHERESProduct and Educational Services, LLCK073293DURETTE IMPLANTOculo Plastik, 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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