Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM

K-Number: K882105 · 1988-07-11

ApplicantDianon Systems, Inc.
Decision Date1988-07-11
Product CodeGAA
Advisory CommitteeSU
DecisionUnknown

Device Summary

CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dianon Systems, Inc.. It received FDA 510(k) clearance on 1988-07-11 under 510(k) number K882105. The device is classified under product code GAA. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM?

CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM is a medical device that received FDA 510(k) clearance on 1988-07-11. The listed applicant is Dianon Systems, Inc.. The 510(k) number is K882105.

When did CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM receive FDA 510(k) clearance?

CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM received FDA 510(k) clearance on 1988-07-11, under 510(k) number K882105.

Who is the listed applicant for CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM?

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

What is the FDA product code for CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM?

The FDA product code for CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM is GAA.

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 Dianon Systems, 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.

K872597FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE

Related Devices (Code: GAA)

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.

K223625CapnoSpot™ Pneumothorax Decompression IndicatorPneumeric, Inc.K102274ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENTArvik Enterprises/ Mini Lap TechnologiesK011586IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGEDiametrics Medical, Inc.K994151PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICESXimed/Prosure/InjectxK983200INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEXXimed/Prosure/InjectxK974741MANAN ACCURA NEEDLEMedical Device Technologies, Inc.

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.

↑