FDA 510(k)

PROSTATE SEEDING NEEDLE

K-Number: K973184 · 1997-11-21

Decision Date1997-11-21

Product CodeIWJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PROSTATE SEEDING NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Promex, Inc.. It received FDA 510(k) clearance on 1997-11-21 under 510(k) number K973184. The device is classified under product code IWJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSTATE SEEDING NEEDLE?

PROSTATE SEEDING NEEDLE is a medical device that received FDA 510(k) clearance on 1997-11-21. The listed applicant is Promex, Inc.. The 510(k) number is K973184.

When did PROSTATE SEEDING NEEDLE receive FDA 510(k) clearance?

PROSTATE SEEDING NEEDLE received FDA 510(k) clearance on 1997-11-21, under 510(k) number K973184.

Who is the listed applicant for PROSTATE SEEDING NEEDLE?

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

What is the FDA product code for PROSTATE SEEDING NEEDLE?

The FDA product code for PROSTATE SEEDING NEEDLE is IWJ.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Promex, Inc. as applicant

K023450BIOPSY SITE TISSUE MARKER DEVICE K022634CO-AXIAL INTRODUCER NEEDLE K010400VACUUM ASSISTED CORE BIOPSY DEVICE K011270AUTOMATED CORE BIOPSY DEVICE K001132BONE BIOPSY NEEDLE K994272AUTOMATED CORE BIOPSY DEVICE

View all 18 devices →

Related Devices (Code: IWJ)

K010166IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEMImagyn Medical Technologies, Inc.K980997PGK DEVICE (MODIFIED)Pgk, Inc.K972554REGANES RADIONUCLIDE SEED MAGAZINEAvid N.I.T., Inc.K973037N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000Avid N.I.T., Inc.K974118WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SETWorldwide Medical Technologies, LLC K973786NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDENw Radiation Therapy Products

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.