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)

INSTRUMED RONGEUR

K-Number: K081651 · 2008-08-08

ApplicantInstrumed International, Inc.
Decision Date2008-08-08
Product CodeHAE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INSTRUMED RONGEUR is the device name listed in this FDA 510(k) record. The listed applicant is Instrumed International, Inc.. It received FDA 510(k) clearance on 2008-08-08 under 510(k) number K081651. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTRUMED RONGEUR?

INSTRUMED RONGEUR is a medical device that received FDA 510(k) clearance on 2008-08-08. The listed applicant is Instrumed International, Inc.. The 510(k) number is K081651.

When did INSTRUMED RONGEUR receive FDA 510(k) clearance?

INSTRUMED RONGEUR received FDA 510(k) clearance on 2008-08-08, under 510(k) number K081651.

Who is the listed applicant for INSTRUMED RONGEUR?

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

What is the FDA product code for INSTRUMED RONGEUR?

The FDA product code for INSTRUMED RONGEUR is HAE.

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 Instrumed International, 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.

K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054K100517INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXXK092840INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICALK092544INSTRUMED VASCULAR CLAMPSK071771INSTRUMED RETRACTORSK040855INSTRUMED LAPAROSCOPE AND ACCESSORIES

View all 7 devices →

Related Devices (Code: HAE)

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.

K260446Tontarra Punches and RongeursTontarra Medizintechnik GmbHK242759Geister K-Rex rongeursGeister Medizin Technik GmbHK223596SQ.line KERRISONAesculap, Inc.K230256Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AGK221818Rebellion; Phantom Multi-Bite Kerrison RongeurMorpheus AGK210741KLS Martin Neuro RongeursKLS-Martin L.P.

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.

↑