Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MEDPOR SURGICAL IMPLANT MATERIAL

K-Number: K943275 · 1994-09-02

ApplicantPorex Surgical, Inc.
Decision Date1994-09-02
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MEDPOR SURGICAL IMPLANT MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Porex Surgical, Inc.. It received FDA 510(k) clearance on 1994-09-02 under 510(k) number K943275. 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 MEDPOR SURGICAL IMPLANT MATERIAL?

MEDPOR SURGICAL IMPLANT MATERIAL is a medical device that received FDA 510(k) clearance on 1994-09-02. The listed applicant is Porex Surgical, Inc.. The 510(k) number is K943275.

When did MEDPOR SURGICAL IMPLANT MATERIAL receive FDA 510(k) clearance?

MEDPOR SURGICAL IMPLANT MATERIAL received FDA 510(k) clearance on 1994-09-02, under 510(k) number K943275.

Who is the listed applicant for MEDPOR SURGICAL IMPLANT MATERIAL?

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

What is the FDA product code for MEDPOR SURGICAL IMPLANT MATERIAL?

The FDA product code for MEDPOR SURGICAL IMPLANT MATERIAL is HPZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Porex Surgical, 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.

K102184MEDPOR CONTAIN CAN IMPLANTK101835MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079K091807MEDPOR FIXATION SYSTEMK091120MEDPOR CONTAIN IMPLANTK083621MEDPOR CUSTOMIZED SURGICAL IMPLANTK071335MEDPOR ATTRACTOR IMPLANT

View all 19 devices →

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.K112176SILICONE SPHERESOculo Plastik, Inc.K083342ORBITAL RECONSTRUCTIVE IMPLANT IIEvera Medical, Inc.K082850EYE SPHERESProduct and Educational Services, LLC

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.

↑