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FDA 510(k)

CAT. 3 GASTROENTEROLOGY-UROLOGY DEV

K-Number: K840307 · 1984-03-12

ApplicantImm Enterprises , Ltd.
Decision Date1984-03-12
Product CodeHTD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CAT. 3 GASTROENTEROLOGY-UROLOGY DEV 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 1984-03-12 under 510(k) number K840307. The device is classified under product code HTD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAT. 3 GASTROENTEROLOGY-UROLOGY DEV?

CAT. 3 GASTROENTEROLOGY-UROLOGY DEV is a medical device that received FDA 510(k) clearance on 1984-03-12. The listed applicant is Imm Enterprises , Ltd.. The 510(k) number is K840307.

When did CAT. 3 GASTROENTEROLOGY-UROLOGY DEV receive FDA 510(k) clearance?

CAT. 3 GASTROENTEROLOGY-UROLOGY DEV received FDA 510(k) clearance on 1984-03-12, under 510(k) number K840307.

Who is the listed applicant for CAT. 3 GASTROENTEROLOGY-UROLOGY DEV?

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 CAT. 3 GASTROENTEROLOGY-UROLOGY DEV?

The FDA product code for CAT. 3 GASTROENTEROLOGY-UROLOGY DEV is HTD.

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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: HTD)

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.

K051281THE NEEDLE CATCHERE.D.Medical , Ltd.K974595CUSHING BAYONET, INSULATED BIPOLAR FORCEPTitan Mfg., Inc.K974594SEMKIN BIPOLAR FORCEPTitan Mfg., Inc.K974593SEMKIN INSULATED BIPOLAR FORCEPTitan Mfg., Inc.K913964MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPSMarlo Surgical TechnologyK911180CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPSNorthgate Technologies, 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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