Cleared Traditional

JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)

K952350 · Promedical , Ltd. · General Hospital

Jul 1995

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K952350 is an FDA 510(k) clearance for the JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN), a Bone Marrow Collection/transfusion Kit (Class II — Special Controls, product code LWE), submitted by Promedical , Ltd. (Wyckoff, US). The FDA issued a Cleared decision on July 17, 1995, 59 days after receiving the submission on May 19, 1995. This device falls under the General Hospital review panel.

Submission Details

510(k) Number	K952350 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 1995
Decision Date	July 17, 1995
Days to Decision	59 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	LWE — Bone Marrow Collection/transfusion Kit
Device Class	Class II — Special Controls
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html.this Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.