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FDA 510(k)

BONE MARROW BIOPSY SYSTEM

K-Number: K923872 · 1992-12-15

ApplicantThe Straumann Co.
Decision Date1992-12-15
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BONE MARROW BIOPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is The Straumann Co.. It received FDA 510(k) clearance on 1992-12-15 under 510(k) number K923872. The device is classified under product code GDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE MARROW BIOPSY SYSTEM?

BONE MARROW BIOPSY SYSTEM is a medical device that received FDA 510(k) clearance on 1992-12-15. The listed applicant is The Straumann Co.. The 510(k) number is K923872.

When did BONE MARROW BIOPSY SYSTEM receive FDA 510(k) clearance?

BONE MARROW BIOPSY SYSTEM received FDA 510(k) clearance on 1992-12-15, under 510(k) number K923872.

Who is the listed applicant for BONE MARROW BIOPSY SYSTEM?

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

What is the FDA product code for BONE MARROW BIOPSY SYSTEM?

The FDA product code for BONE MARROW BIOPSY SYSTEM is GDM.

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Other records listing The Straumann Co. 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.

K041070STRAUMANN TEMPORARY COPINGK040646STRAUMANN GRANULESK040469THE STRAUMANN ORTHO IMPLANT SYSTEMK993862MODUS SAGITTAL SPLIT PLATEK962023PLASTIC PROTECTION HEALING CAPSK960634TITANIUM HEALING CAPS

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Related Devices (Code: GDM)

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.

K071732MARROWMINERStemcor Systems, Inc.K971114BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K953082ILIAC CREST BONE MARROW ASPIRATION NEEDLEBaxter Healthcare CorpK953064BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K936207ENDO-NEEDLE INSTRUMENTGerard Medical, Inc.K930160ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLESymbiosis Corp.

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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