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FDA 510(k)

PLEURAL BIOPSY PUNCH NEEDLE

K-Number: K881624 · 1988-08-11

ApplicantE.G. Dick & Assoc.
Decision Date1988-08-11
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PLEURAL BIOPSY PUNCH NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is E.G. Dick & Assoc.. It received FDA 510(k) clearance on 1988-08-11 under 510(k) number K881624. 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 PLEURAL BIOPSY PUNCH NEEDLE?

PLEURAL BIOPSY PUNCH NEEDLE is a medical device that received FDA 510(k) clearance on 1988-08-11. The listed applicant is E.G. Dick & Assoc.. The 510(k) number is K881624.

When did PLEURAL BIOPSY PUNCH NEEDLE receive FDA 510(k) clearance?

PLEURAL BIOPSY PUNCH NEEDLE received FDA 510(k) clearance on 1988-08-11, under 510(k) number K881624.

Who is the listed applicant for PLEURAL BIOPSY PUNCH NEEDLE?

The FDA 510(k) record lists E.G. Dick & Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLEURAL BIOPSY PUNCH NEEDLE?

The FDA product code for PLEURAL BIOPSY PUNCH 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 E.G. Dick & Assoc. 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.

K883876WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLEK881854SORBSAN TOPICAL WOUND DRESSING

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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