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FDA 510(k)

SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE

K-Number: K921671 · 1992-06-18

ApplicantSurgical Products Corp.
Decision Date1992-06-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Products Corp.. It received FDA 510(k) clearance on 1992-06-18 under 510(k) number K921671. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE?

SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE is a medical device that received FDA 510(k) clearance on 1992-06-18. The listed applicant is Surgical Products Corp.. The 510(k) number is K921671.

When did SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE receive FDA 510(k) clearance?

SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE received FDA 510(k) clearance on 1992-06-18, under 510(k) number K921671.

Who is the listed applicant for SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE?

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

What is the FDA product code for SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE?

The FDA product code for SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE is GEX. This falls under the Gastroenterology category.

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Other records listing Surgical Products Corp. 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.

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Related Devices (Code: GEX)

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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