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FDA 510(k)

CAUTERY TIP CLEANER, MODEL-TC-100

K-Number: K030339 · 2003-03-07

ApplicantAspen Surgical Products, Inc.
Decision Date2003-03-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CAUTERY TIP CLEANER, MODEL-TC-100 is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Surgical Products, Inc.. It received FDA 510(k) clearance on 2003-03-07 under 510(k) number K030339. 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 CAUTERY TIP CLEANER, MODEL-TC-100?

CAUTERY TIP CLEANER, MODEL-TC-100 is a medical device that received FDA 510(k) clearance on 2003-03-07. The listed applicant is Aspen Surgical Products, Inc.. The 510(k) number is K030339.

When did CAUTERY TIP CLEANER, MODEL-TC-100 receive FDA 510(k) clearance?

CAUTERY TIP CLEANER, MODEL-TC-100 received FDA 510(k) clearance on 2003-03-07, under 510(k) number K030339.

Who is the listed applicant for CAUTERY TIP CLEANER, MODEL-TC-100?

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

What is the FDA product code for CAUTERY TIP CLEANER, MODEL-TC-100?

The FDA product code for CAUTERY TIP CLEANER, MODEL-TC-100 is GEI.

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.

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Other records listing Aspen Surgical Products, Inc. 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.

K020304DISPOSABLE LIGHT HANDLE AND ADAPTOR

Related Devices (Code: GEI)

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.

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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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