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FDA 510(k)

BIOSIL MEDICAL GRADE SILICONE SHEETING

K-Number: K932176 · 1993-12-02

ApplicantBioplexus Corp.
Decision Date1993-12-02
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BIOSIL MEDICAL GRADE SILICONE SHEETING is the device name listed in this FDA 510(k) record. The listed applicant is Bioplexus Corp.. It received FDA 510(k) clearance on 1993-12-02 under 510(k) number K932176. The device is classified under product code KHJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSIL MEDICAL GRADE SILICONE SHEETING?

BIOSIL MEDICAL GRADE SILICONE SHEETING is a medical device that received FDA 510(k) clearance on 1993-12-02. The listed applicant is Bioplexus Corp.. The 510(k) number is K932176.

When did BIOSIL MEDICAL GRADE SILICONE SHEETING receive FDA 510(k) clearance?

BIOSIL MEDICAL GRADE SILICONE SHEETING received FDA 510(k) clearance on 1993-12-02, under 510(k) number K932176.

Who is the listed applicant for BIOSIL MEDICAL GRADE SILICONE SHEETING?

The FDA 510(k) record lists Bioplexus Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSIL MEDICAL GRADE SILICONE SHEETING?

The FDA product code for BIOSIL MEDICAL GRADE SILICONE SHEETING is KHJ.

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 Bioplexus Corp. 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.

K952732MEDICAL GRADE SILICONE BLOCKK933827BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS

Related Devices (Code: KHJ)

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.

K260266Tympendi™ (810)Grace Medical, Inc.K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)Cook Biotech IncorporatedK161000Biodesign Otologic Repair GraftCook Biotech IncorporatedK132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAICeremed , Inc.K121360BIODESIGN ENT REPAIR GRAFTCook Biotech IncorpratedK122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINCeremed , Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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