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FDA 510(k)

SYNERGY

K-Number: K083378 · 2009-09-29

ApplicantInnerspace, Inc.
Decision Date2009-09-29
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SYNERGY is the device name listed in this FDA 510(k) record. The listed applicant is Innerspace, Inc.. It received FDA 510(k) clearance on 2009-09-29 under 510(k) number K083378. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNERGY?

SYNERGY is a medical device that received FDA 510(k) clearance on 2009-09-29. The listed applicant is Innerspace, Inc.. The 510(k) number is K083378.

When did SYNERGY receive FDA 510(k) clearance?

SYNERGY received FDA 510(k) clearance on 2009-09-29, under 510(k) number K083378.

Who is the listed applicant for SYNERGY?

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

What is the FDA product code for SYNERGY?

The FDA product code for SYNERGY is GWM.

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Related Devices (Code: GWM)

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

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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