Spacer

FDA 510(k) K925870 · Bip USA, Inc.

Substantially Equivalent

510(k) numberK925870

Submission

Device name
Spacer
Applicant
Bip USA, Inc.
Niagara Falls, NY, US
Received
November 19, 1992
Decision date
May 19, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MJG – Device, Percutaneous, Biopsy
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code MJG

510(k)DeviceApplicantDecision
K080674Pajunk's Primocut Disposable Biopsy SystemMJG · Traditional PAJUNK GmbH Medizintechnologie05/09/2008SE
K070836Exiclip Excs-MMJG · Traditional Clevex, Inc.04/20/2007SE
K983647Echo-Coat Ultrasound NeedlesMJG · Traditional Sts Biopolymers01/20/1999SE
K955683RNS Sterile, Disposable Breast Biopsy/Localization TrayMJG · Traditional Contour Fabricators of Florida, Inc.02/01/1996SE
K933324Skin Biopsy DeviceMJG · Traditional Nhr, Inc.03/31/1994SE
K922919Dynacyt Biopsy Aspiration DeviceMJG · Traditional Buckman Co., Inc.03/31/1993SE

More from Buckman Co., Inc.

510(k)DeviceDecision
K024089Vacuflash Biopsy SystemKNW · Traditional 03/11/2003SE
K934371Bip Multi ModificationKNW · Traditional 04/28/1994SE
K934370Bip Biopsy Needle ModificationFCG · Traditional 03/07/1994SE
K935457Localization Wire or Marker - SurgicalGDF · Traditional 02/17/1994SE
K925875Horizontal Needle Guide AttachmentGDF · Traditional 04/06/1993SE
K925874Breast StabilizerMDM · Traditional 03/16/1993SE

Questions and answers

When was Spacer cleared by the FDA?

Spacer (K925870) received a 510(k) decision of Substantially Equivalent on May 19, 1993, 181 days after the submission was received.

What is the product code of K925870?

The FDA product code is MJG – Device, Percutaneous, Biopsy, a Class I (low risk) device regulated under 21 CFR 878.4800.