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FDA 510(k)

HOTIP HEMOSTATIC PROBE

K-Number: K843628 · 1985-11-12

ApplicantTrimedyne, Inc.
Decision Date1985-11-12
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HOTIP HEMOSTATIC PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1985-11-12 under 510(k) number K843628. The device is classified under product code LNK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOTIP HEMOSTATIC PROBE?

HOTIP HEMOSTATIC PROBE is a medical device that received FDA 510(k) clearance on 1985-11-12. The listed applicant is Trimedyne, Inc.. The 510(k) number is K843628.

When did HOTIP HEMOSTATIC PROBE receive FDA 510(k) clearance?

HOTIP HEMOSTATIC PROBE received FDA 510(k) clearance on 1985-11-12, under 510(k) number K843628.

Who is the listed applicant for HOTIP HEMOSTATIC PROBE?

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

What is the FDA product code for HOTIP HEMOSTATIC PROBE?

The FDA product code for HOTIP HEMOSTATIC PROBE is LNK.

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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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