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FDA 510(k)

CHESS HAND SURGERY SYSTEM

K-Number: K010184 · 2001-06-22

ApplicantCanica Design, Inc.
Decision Date2001-06-22
Product CodeMDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CHESS HAND SURGERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Canica Design, Inc.. It received FDA 510(k) clearance on 2001-06-22 under 510(k) number K010184. The device is classified under product code MDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHESS HAND SURGERY SYSTEM?

CHESS HAND SURGERY SYSTEM is a medical device that received FDA 510(k) clearance on 2001-06-22. The listed applicant is Canica Design, Inc.. The 510(k) number is K010184.

When did CHESS HAND SURGERY SYSTEM receive FDA 510(k) clearance?

CHESS HAND SURGERY SYSTEM received FDA 510(k) clearance on 2001-06-22, under 510(k) number K010184.

Who is the listed applicant for CHESS HAND SURGERY SYSTEM?

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

What is the FDA product code for CHESS HAND SURGERY SYSTEM?

The FDA product code for CHESS HAND SURGERY SYSTEM is MDM.

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Related Devices (Code: MDM)

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.

K073664FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCERInjectimed, Inc.K050575FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEMFutumeds Sdn BhdK050957EUTROCHARSpecial Devices, Inc.K023173ANDREWS INTRODUCER, MODEL ASI01Andrews Surgical Innovations, Ltd.K022059MICROVASIVE PULMONARY GUIDEWIREBoston Scientific CorpK013040LIGHT SABER INTRODUCER NEEDLEMinrad, Inc.

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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