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FDA 510(k)

HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE

K-Number: K032969 · 2004-02-04

ApplicantHelica Instruments, Ltd.
Decision Date2004-02-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Helica Instruments, Ltd.. It received FDA 510(k) clearance on 2004-02-04 under 510(k) number K032969. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE?

HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE is a medical device that received FDA 510(k) clearance on 2004-02-04. The listed applicant is Helica Instruments, Ltd.. The 510(k) number is K032969.

When did HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE receive FDA 510(k) clearance?

HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE received FDA 510(k) clearance on 2004-02-04, under 510(k) number K032969.

Who is the listed applicant for HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE?

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

What is the FDA product code for HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE?

The FDA product code for HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE is GEI.

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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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