FDA 510(k)

HEMORRHAGE OCCLUDOR

K-Number: K890447 · 1989-02-23

ApplicantSurgeon Surgical Instrumentation, Inc.

Decision Date1989-02-23

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HEMORRHAGE OCCLUDOR is the device name listed in this FDA 510(k) record. The listed applicant is Surgeon Surgical Instrumentation, Inc.. It received FDA 510(k) clearance on 1989-02-23 under 510(k) number K890447. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMORRHAGE OCCLUDOR?

HEMORRHAGE OCCLUDOR is a medical device that received FDA 510(k) clearance on 1989-02-23. The listed applicant is Surgeon Surgical Instrumentation, Inc.. The 510(k) number is K890447.

When did HEMORRHAGE OCCLUDOR receive FDA 510(k) clearance?

HEMORRHAGE OCCLUDOR received FDA 510(k) clearance on 1989-02-23, under 510(k) number K890447.

Who is the listed applicant for HEMORRHAGE OCCLUDOR?

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

What is the FDA product code for HEMORRHAGE OCCLUDOR?

The FDA product code for HEMORRHAGE OCCLUDOR is GDW.

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 Surgeon Surgical Instrumentation, Inc. as applicant

K954241SURGIN GENISIS PHACOEMULSIFIER K932281VERRES NEEDLE K922038CO2 INSUFFLATION TUBING K904010SURGICAL ASPIRATOR KIT K880543UNI-PORT K881232SURGIN EYE SHIELD

View all 10 devices →

Related Devices (Code: GDW)

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.