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FDA 510(k)

NOVATOME, MODEL: SU101-50

K-Number: K072051 · 2007-10-03

ApplicantScholten Surgical Instruments, Inc.
Decision Date2007-10-03
Product CodeDWZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOVATOME, MODEL: SU101-50 is the device name listed in this FDA 510(k) record. The listed applicant is Scholten Surgical Instruments, Inc.. It received FDA 510(k) clearance on 2007-10-03 under 510(k) number K072051. The device is classified under product code DWZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVATOME, MODEL: SU101-50?

NOVATOME, MODEL: SU101-50 is a medical device that received FDA 510(k) clearance on 2007-10-03. The listed applicant is Scholten Surgical Instruments, Inc.. The 510(k) number is K072051.

When did NOVATOME, MODEL: SU101-50 receive FDA 510(k) clearance?

NOVATOME, MODEL: SU101-50 received FDA 510(k) clearance on 2007-10-03, under 510(k) number K072051.

Who is the listed applicant for NOVATOME, MODEL: SU101-50?

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

What is the FDA product code for NOVATOME, MODEL: SU101-50?

The FDA product code for NOVATOME, MODEL: SU101-50 is DWZ.

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Other records listing Scholten Surgical Instruments, Inc. as applicant

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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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