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FDA 510(k)

KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS

K-Number: K852477 · 1985-07-30

ApplicantMayo Clinic
Decision Date1985-07-30
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS is the device name listed in this FDA 510(k) record. The listed applicant is Mayo Clinic. It received FDA 510(k) clearance on 1985-07-30 under 510(k) number K852477. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS?

KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS is a medical device that received FDA 510(k) clearance on 1985-07-30. The listed applicant is Mayo Clinic. The 510(k) number is K852477.

When did KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS receive FDA 510(k) clearance?

KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS received FDA 510(k) clearance on 1985-07-30, under 510(k) number K852477.

Who is the listed applicant for KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS?

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

What is the FDA product code for KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS?

The FDA product code for KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS is HAW.

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Other records listing Mayo Clinic as applicant

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.

K040122MAYO CLINIC BC-10 3.0TK943230MAYO HIP PROSTHESIS

Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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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