FDA 510(k)

OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01

K-Number: K980159 · 1998-04-09

Decision Date1998-04-09

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 is the device name listed in this FDA 510(k) record. The listed applicant is Closure Medical Corp.. It received FDA 510(k) clearance on 1998-04-09 under 510(k) number K980159. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01?

OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 is a medical device that received FDA 510(k) clearance on 1998-04-09. The listed applicant is Closure Medical Corp.. The 510(k) number is K980159.

When did OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 receive FDA 510(k) clearance?

OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 received FDA 510(k) clearance on 1998-04-09, under 510(k) number K980159.

Who is the listed applicant for OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01?

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

What is the FDA product code for OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01?

The FDA product code for OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 is EMA.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Closure Medical Corp. as applicant

K002338LIQUIDERM LIQUID ADHESIVE BANDAGE K991923SOOTHE-N-SEAL CANKER SORE RELIEF

Related Devices (Code: EMA)

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak K261166DIA-CEMDiaDent Group International K254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, 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.