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FDA 510(k)

FULACCESS MODEL 1.0

K-Number: K101707 · 2010-10-29

ApplicantFulcrum Medical, Inc.
Decision Date2010-10-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FULACCESS MODEL 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Fulcrum Medical, Inc.. It received FDA 510(k) clearance on 2010-10-29 under 510(k) number K101707. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FULACCESS MODEL 1.0?

FULACCESS MODEL 1.0 is a medical device that received FDA 510(k) clearance on 2010-10-29. The listed applicant is Fulcrum Medical, Inc.. The 510(k) number is K101707.

When did FULACCESS MODEL 1.0 receive FDA 510(k) clearance?

FULACCESS MODEL 1.0 received FDA 510(k) clearance on 2010-10-29, under 510(k) number K101707.

Who is the listed applicant for FULACCESS MODEL 1.0?

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

What is the FDA product code for FULACCESS MODEL 1.0?

The FDA product code for FULACCESS MODEL 1.0 is LLZ.

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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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