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FDA 510(k)

BIOSURGE MODEL OASYS

K-Number: K871258 · 1987-05-21

ApplicantBiosurge, Inc.
Decision Date1987-05-21
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIOSURGE MODEL OASYS is the device name listed in this FDA 510(k) record. The listed applicant is Biosurge, Inc.. It received FDA 510(k) clearance on 1987-05-21 under 510(k) number K871258. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSURGE MODEL OASYS?

BIOSURGE MODEL OASYS is a medical device that received FDA 510(k) clearance on 1987-05-21. The listed applicant is Biosurge, Inc.. The 510(k) number is K871258.

When did BIOSURGE MODEL OASYS receive FDA 510(k) clearance?

BIOSURGE MODEL OASYS received FDA 510(k) clearance on 1987-05-21, under 510(k) number K871258.

Who is the listed applicant for BIOSURGE MODEL OASYS?

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

What is the FDA product code for BIOSURGE MODEL OASYS?

The FDA product code for BIOSURGE MODEL OASYS is CAC.

Related Clinical Trials

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.

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Other records listing Biosurge, 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.

K884620ASD SINGLE LUMEN NEEDLEK875016BIOSURGE MODEL ILVC-1K874602ASD-BIO ANTI-STICK DEVICEK875023BIOSURGE MODEL OASYS-II

Related Devices (Code: CAC)

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.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation

Official Source

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