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FDA 510(k)

SPECTRA MEDICAL SAFETY SCAPEL

K-Number: K091462 · 2009-12-15

ApplicantSpectra, Inc.
Decision Date2009-12-15
Product CodeGDZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPECTRA MEDICAL SAFETY SCAPEL is the device name listed in this FDA 510(k) record. The listed applicant is Spectra, Inc.. It received FDA 510(k) clearance on 2009-12-15 under 510(k) number K091462. The device is classified under product code GDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRA MEDICAL SAFETY SCAPEL?

SPECTRA MEDICAL SAFETY SCAPEL is a medical device that received FDA 510(k) clearance on 2009-12-15. The listed applicant is Spectra, Inc.. The 510(k) number is K091462.

When did SPECTRA MEDICAL SAFETY SCAPEL receive FDA 510(k) clearance?

SPECTRA MEDICAL SAFETY SCAPEL received FDA 510(k) clearance on 2009-12-15, under 510(k) number K091462.

Who is the listed applicant for SPECTRA MEDICAL SAFETY SCAPEL?

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

What is the FDA product code for SPECTRA MEDICAL SAFETY SCAPEL?

The FDA product code for SPECTRA MEDICAL SAFETY SCAPEL is GDZ.

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Related Devices (Code: GDZ)

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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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