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)

OBTURATION SYSTEM KIT

K-Number: K820639 · 1982-04-09

ApplicantU.S. Shizai Corp.
Decision Date1982-04-09
Product CodeEKM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OBTURATION SYSTEM KIT is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Shizai Corp.. It received FDA 510(k) clearance on 1982-04-09 under 510(k) number K820639. The device is classified under product code EKM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OBTURATION SYSTEM KIT?

OBTURATION SYSTEM KIT is a medical device that received FDA 510(k) clearance on 1982-04-09. The listed applicant is U.S. Shizai Corp.. The 510(k) number is K820639.

When did OBTURATION SYSTEM KIT receive FDA 510(k) clearance?

OBTURATION SYSTEM KIT received FDA 510(k) clearance on 1982-04-09, under 510(k) number K820639.

Who is the listed applicant for OBTURATION SYSTEM KIT?

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

What is the FDA product code for OBTURATION SYSTEM KIT?

The FDA product code for OBTURATION SYSTEM KIT is EKM.

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 U.S. Shizai 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.

K853841HARMO SONICK822464OBTURATION GUTTAK802189DENTLOIDK800951CASTA-LLOY

Related Devices (Code: EKM)

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.

K073369EI DOWNPAK BARRIER SLEEVESHu-Friedy Mfg. Co., Inc.K070246DOWN PAKEndo Twinn B.V.K051573TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)Dr. Howard Martin, P.A.K042870ENDO TWINNEndo Twinn B.V.K023819FIBERFILL SGPPentron Clinical TechnologiesK971641ANTIBACTERIAL GUTTA PERCHADr. Howard Martin, P.A.

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.

↑