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FDA 510(k)

JAKOBI SURGICAL INSTRUMENTS #3 17/18/19

K-Number: K834191 · 1984-03-22

ApplicantImm Enterprises , Ltd.
Decision Date1984-03-22
Product CodeKOA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 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 1984-03-22 under 510(k) number K834191. 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 JAKOBI SURGICAL INSTRUMENTS #3 17/18/19?

JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 is a medical device that received FDA 510(k) clearance on 1984-03-22. The listed applicant is Imm Enterprises , Ltd.. The 510(k) number is K834191.

When did JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 receive FDA 510(k) clearance?

JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 received FDA 510(k) clearance on 1984-03-22, under 510(k) number K834191.

Who is the listed applicant for JAKOBI SURGICAL INSTRUMENTS #3 17/18/19?

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 JAKOBI SURGICAL INSTRUMENTS #3 17/18/19?

The FDA product code for JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 is KOA.

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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

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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.

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