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FDA 510(k)

SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE

K-Number: K851659 · 1985-07-01

ApplicantMedco Products, Co., Inc.
Decision Date1985-07-01
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medco Products, Co., Inc.. It received FDA 510(k) clearance on 1985-07-01 under 510(k) number K851659. 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 SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE?

SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE is a medical device that received FDA 510(k) clearance on 1985-07-01. The listed applicant is Medco Products, Co., Inc.. The 510(k) number is K851659.

When did SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE receive FDA 510(k) clearance?

SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE received FDA 510(k) clearance on 1985-07-01, under 510(k) number K851659.

Who is the listed applicant for SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE?

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

What is the FDA product code for SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE?

The FDA product code for SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE is HAW.

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Other records listing Medco Products, Co., Inc. 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.

K932466MEDCHEM SURGICAL DELIVERY SYSTEMK913172ENDOSCOPIC DELIVERY SYSTEMK860099MEDCO-SONIC NQ-2000K852015JYROCHAIR, MODEL SK-HK844580MEDCOLATOR MODEL HVXK842712MEDCOLATOR MODEL GX

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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

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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