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FDA 510(k)

DISPOSABLE LIGHT HANDLE AND ADAPTOR

K-Number: K020304 · 2002-02-14

ApplicantAspen Surgical Products, Inc.
Decision Date2002-02-14
Product CodeFTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE LIGHT HANDLE AND ADAPTOR 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 2002-02-14 under 510(k) number K020304. The device is classified under product code FTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE LIGHT HANDLE AND ADAPTOR?

DISPOSABLE LIGHT HANDLE AND ADAPTOR is a medical device that received FDA 510(k) clearance on 2002-02-14. The listed applicant is Aspen Surgical Products, Inc.. The 510(k) number is K020304.

When did DISPOSABLE LIGHT HANDLE AND ADAPTOR receive FDA 510(k) clearance?

DISPOSABLE LIGHT HANDLE AND ADAPTOR received FDA 510(k) clearance on 2002-02-14, under 510(k) number K020304.

Who is the listed applicant for DISPOSABLE LIGHT HANDLE AND ADAPTOR?

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 DISPOSABLE LIGHT HANDLE AND ADAPTOR?

The FDA product code for DISPOSABLE LIGHT HANDLE AND ADAPTOR is FTA.

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.

K030339CAUTERY TIP CLEANER, MODEL-TC-100

Related Devices (Code: FTA)

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.

K112133OASYS SURGICAL LIGHT CONTROLLEROasys HealthcareK102791EASYSUITE SURGICAL LIGHT CONTROL (ESLC)Image Stream Medical, Inc.K081698MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)Image Stream Medical, Inc.K053321LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVERXodus Medical, Inc.K051505SCB/STERIS OR-LIGHT INTERFACE BOXKARL STORZ Endoscopy-America, Inc.K023704KSEA SCB ACC CONTROLKARL STORZ Endoscopy-America, 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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