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FDA 510(k)

STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)

K-Number: K954726 · 1995-11-29

ApplicantStryker Endoscopy
Decision Date1995-11-29
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 1995-11-29 under 510(k) number K954726. The device is classified under product code GCX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)?

STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1995-11-29. The listed applicant is Stryker Endoscopy. The 510(k) number is K954726.

When did STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) receive FDA 510(k) clearance?

STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) received FDA 510(k) clearance on 1995-11-29, under 510(k) number K954726.

Who is the listed applicant for STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)?

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

What is the FDA product code for STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)?

The FDA product code for STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) is GCX.

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Related Devices (Code: GCX)

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.

K042454STRYKER CASSETTE PUMPStryker EndoscopyK992126CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEMCircon Corp.K972074SUCTION INSTRUMENTATIONWalter Lorenz Surgical, Inc.K971022CHASE SUCKERChase Medical, Inc.K964127MEDI-VAC FLEXI-CLEAR SUCTION HANDLEAllegiance Healthcare Corp.K964519CURITY THORACENTESIS TRAYKendall Healthcare Products Co. Div.Of Tyco Health

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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