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FDA 510(k)

NEUROSURGICAL INSTURMENTS (VARIOUS)

K-Number: K861630 · 1986-05-09

ApplicantDowns Surgical , Ltd.
Decision Date1986-05-09
Product CodeHAO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROSURGICAL INSTURMENTS (VARIOUS) is the device name listed in this FDA 510(k) record. The listed applicant is Downs Surgical , Ltd.. It received FDA 510(k) clearance on 1986-05-09 under 510(k) number K861630. The device is classified under product code HAO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROSURGICAL INSTURMENTS (VARIOUS)?

NEUROSURGICAL INSTURMENTS (VARIOUS) is a medical device that received FDA 510(k) clearance on 1986-05-09. The listed applicant is Downs Surgical , Ltd.. The 510(k) number is K861630.

When did NEUROSURGICAL INSTURMENTS (VARIOUS) receive FDA 510(k) clearance?

NEUROSURGICAL INSTURMENTS (VARIOUS) received FDA 510(k) clearance on 1986-05-09, under 510(k) number K861630.

Who is the listed applicant for NEUROSURGICAL INSTURMENTS (VARIOUS)?

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

What is the FDA product code for NEUROSURGICAL INSTURMENTS (VARIOUS)?

The FDA product code for NEUROSURGICAL INSTURMENTS (VARIOUS) is HAO.

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Other records listing Downs Surgical , Ltd. 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.

K903750ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-EK903747ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-UK903749ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-UK903748ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-VK900609SHEPPERD STRAIGHT AND CURVED NEEDLESK900616SHEPPERD CUTTING FORCEPS

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Related Devices (Code: HAO)

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.

K220920Matreneu Percutaneous Balloon Compression KitShenzhen Shineyard Medical Device Co. , Ltd.K940973MULLAN GANGLION MICROCOMPRESSION SETCook, Inc.K951492RIB RESECTORUnited States Surgical, A Division of Tyco HealthcK943115AUTO SUTURE PITUITARY SPINAL RONGEURUnited States Surgical, A Division of Tyco HealthcK942968AUTO SUTURE SPINAL OSTEOTOMEUnited States Surgical, A Division of Tyco HealthcK942967AUTO SUTURE SPINAL CURETTEUnited States Surgical, A Division of Tyco Healthc

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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