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FDA 510(k)

SHAW II HEMOSTATIC SURGERY SYSTEM

K-Number: K902307 · 1990-08-17

ApplicantHemostatic Surgery Corp.
Decision Date1990-08-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHAW II HEMOSTATIC SURGERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hemostatic Surgery Corp.. It received FDA 510(k) clearance on 1990-08-17 under 510(k) number K902307. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHAW II HEMOSTATIC SURGERY SYSTEM?

SHAW II HEMOSTATIC SURGERY SYSTEM is a medical device that received FDA 510(k) clearance on 1990-08-17. The listed applicant is Hemostatic Surgery Corp.. The 510(k) number is K902307.

When did SHAW II HEMOSTATIC SURGERY SYSTEM receive FDA 510(k) clearance?

SHAW II HEMOSTATIC SURGERY SYSTEM received FDA 510(k) clearance on 1990-08-17, under 510(k) number K902307.

Who is the listed applicant for SHAW II HEMOSTATIC SURGERY SYSTEM?

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

What is the FDA product code for SHAW II HEMOSTATIC SURGERY SYSTEM?

The FDA product code for SHAW II HEMOSTATIC SURGERY SYSTEM is GEI.

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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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