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)

MANAN BREST TUMOR LOCALIZATION NEEDLE

K-Number: K863848 · 1986-10-14

ApplicantManan Manufacturing Co., Inc.
Decision Date1986-10-14
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MANAN BREST TUMOR LOCALIZATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Manan Manufacturing Co., Inc.. It received FDA 510(k) clearance on 1986-10-14 under 510(k) number K863848. The device is classified under product code GAA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANAN BREST TUMOR LOCALIZATION NEEDLE?

MANAN BREST TUMOR LOCALIZATION NEEDLE is a medical device that received FDA 510(k) clearance on 1986-10-14. The listed applicant is Manan Manufacturing Co., Inc.. The 510(k) number is K863848.

When did MANAN BREST TUMOR LOCALIZATION NEEDLE receive FDA 510(k) clearance?

MANAN BREST TUMOR LOCALIZATION NEEDLE received FDA 510(k) clearance on 1986-10-14, under 510(k) number K863848.

Who is the listed applicant for MANAN BREST TUMOR LOCALIZATION NEEDLE?

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

What is the FDA product code for MANAN BREST TUMOR LOCALIZATION NEEDLE?

The FDA product code for MANAN BREST TUMOR LOCALIZATION NEEDLE 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 Manan Manufacturing Co., 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.

K873208MANAN TURNER STYLE NEEDLEK864405MANAN CONTRAST MEDIA ADMINISTRATION SETK852018ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHRK851832NAMAN POTTS COURNAND NEEDLEK852501MYELOGRAM PROCEDURE TRAYK851834MANAN GWI GUIDE WIRE INTRODUCER

View all 20 devices →

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.

↑