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FDA 510(k)

JAIN SUTURE/VESIBAND ORGANIZER

K-Number: K905105 · 1991-01-31

ApplicantJain Surgical Equipment, Inc.
Decision Date1991-01-31
Product CodeMDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

JAIN SUTURE/VESIBAND ORGANIZER is the device name listed in this FDA 510(k) record. The listed applicant is Jain Surgical Equipment, Inc.. It received FDA 510(k) clearance on 1991-01-31 under 510(k) number K905105. The device is classified under product code MDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAIN SUTURE/VESIBAND ORGANIZER?

JAIN SUTURE/VESIBAND ORGANIZER is a medical device that received FDA 510(k) clearance on 1991-01-31. The listed applicant is Jain Surgical Equipment, Inc.. The 510(k) number is K905105.

When did JAIN SUTURE/VESIBAND ORGANIZER receive FDA 510(k) clearance?

JAIN SUTURE/VESIBAND ORGANIZER received FDA 510(k) clearance on 1991-01-31, under 510(k) number K905105.

Who is the listed applicant for JAIN SUTURE/VESIBAND ORGANIZER?

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

What is the FDA product code for JAIN SUTURE/VESIBAND ORGANIZER?

The FDA product code for JAIN SUTURE/VESIBAND ORGANIZER is MDM.

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 Jain Surgical Equipment, 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.

K913896JAIN BLOOD SHIELDK911077JAIN SUTURE PACKAGE COUNTERK911076JAIN QUICK COUNTK904536JAIN GRAFT ASSIST

Related Devices (Code: MDM)

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.

K073664FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCERInjectimed, Inc.K050575FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEMFutumeds Sdn BhdK050957EUTROCHARSpecial Devices, Inc.K023173ANDREWS INTRODUCER, MODEL ASI01Andrews Surgical Innovations, Ltd.K022059MICROVASIVE PULMONARY GUIDEWIREBoston Scientific CorpK013040LIGHT SABER INTRODUCER NEEDLEMinrad, 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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