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)

OP-CON SURG. INSTRUMENT #3

K-Number: K834171 · 1984-04-04

ApplicantImm Enterprises , Ltd.
Decision Date1984-04-04
Product CodeKOA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OP-CON SURG. INSTRUMENT #3 is the device name listed in this FDA 510(k) record. The listed applicant is Imm Enterprises , Ltd.. It received FDA 510(k) clearance on 1984-04-04 under 510(k) number K834171. The device is classified under product code KOA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OP-CON SURG. INSTRUMENT #3?

OP-CON SURG. INSTRUMENT #3 is a medical device that received FDA 510(k) clearance on 1984-04-04. The listed applicant is Imm Enterprises , Ltd.. The 510(k) number is K834171.

When did OP-CON SURG. INSTRUMENT #3 receive FDA 510(k) clearance?

OP-CON SURG. INSTRUMENT #3 received FDA 510(k) clearance on 1984-04-04, under 510(k) number K834171.

Who is the listed applicant for OP-CON SURG. INSTRUMENT #3?

The FDA 510(k) record lists Imm Enterprises , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OP-CON SURG. INSTRUMENT #3?

The FDA product code for OP-CON SURG. INSTRUMENT #3 is KOA.

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 Imm Enterprises , Ltd. 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.

K840311CAT. 7-EAR, NOSE & THROAT DEVICESK841386KOLLMANN URETHRAL DILATORK841387WESTON RECTAL SNAREK840304CATEGORY 17-MICROBIOLOGY DEVICESK840318CAT. 14-CLINICAL TOXIOLOGY DEVICESK840305CATEGORY 1 CIRCULATORY SYSTEM DEVICE

View all 52 devices →

Related Devices (Code: KOA)

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.

K182664FiXcisionAgency For Medical Innovations GmbHK950267URETHRAL SUTURE GUIDEApplied Medical ResourcesK932465LI VASECTOMYFemcare , Ltd.K921546VASOVASOSTOMY SETCook Urological, Inc.K931181VESITEC SUTURE PASSERVesitec Medical, Inc.K921304DDV LIGATORNorth American Medical, 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.

↑