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FDA 510(k)

ROCKET BONE MARROW NEEDLE

K-Number: K895551 · 1989-10-06

ApplicantA & A Medical, Inc.
Decision Date1989-10-06
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ROCKET BONE MARROW NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is A & A Medical, Inc.. It received FDA 510(k) clearance on 1989-10-06 under 510(k) number K895551. 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 ROCKET BONE MARROW NEEDLE?

ROCKET BONE MARROW NEEDLE is a medical device that received FDA 510(k) clearance on 1989-10-06. The listed applicant is A & A Medical, Inc.. The 510(k) number is K895551.

When did ROCKET BONE MARROW NEEDLE receive FDA 510(k) clearance?

ROCKET BONE MARROW NEEDLE received FDA 510(k) clearance on 1989-10-06, under 510(k) number K895551.

Who is the listed applicant for ROCKET BONE MARROW NEEDLE?

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

What is the FDA product code for ROCKET BONE MARROW NEEDLE?

The FDA product code for ROCKET BONE MARROW NEEDLE is GDM.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing A & A Medical, 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.

K013437SF SH CATHETER, MODEL R65-945K013491HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948K003949TACKER, MODEL R65-933K011512MMODIFICATION TO LAMINARIAK010510BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1K010789CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1

View all 23 devices →

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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