PROSTATE SEEDING NEEDLE— 510(k) K973184

Substantially Equivalent

Promex, Inc.

FDA 510(k) clearance K973184 for PROSTATE SEEDING NEEDLE, Substantially Equivalent on 1997-11-21. Applicant: Promex, Inc.. Device class: 1.

Clearance details

Applicant: Promex, Inc.
Product code: Code IWJ
Device class: Class 1
Regulation: 21 CFR 892.5650
Advisory panel: Radiology
Date received: 1997-08-25
Decision date: 1997-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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K974118 — WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET1998-01-23

More clearances from Promex, Inc.

K023450 — BIOPSY SITE TISSUE MARKER DEVICE2002-12-19
K022634 — CO-AXIAL INTRODUCER NEEDLE2002-11-06
K010400 — VACUUM ASSISTED CORE BIOPSY DEVICE2001-07-24
K011270 — AUTOMATED CORE BIOPSY DEVICE2001-06-22
K001132 — BONE BIOPSY NEEDLE2000-05-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.