ClearanceBrief
Panels › Gastroenterology, Urology › Product code FCH · Class 1

Tray, Biopsy, Without Biopsy Instruments

Regulation 876.4730

0510(k)s in 12 months (2 all time)
0recalls in 12 months (14 all time)
0recalls that name a 510(k)
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Top companies in FCH

DateFirm and productCodeLinked 510(k)
Oct 16, 2025American Contract Systems Inc.
Basic Biopsy Tray, Item Number NMBP44L
Open, Classified
FCHNone listed
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O ; 2) BONE RETRIEVAL PART A , Pack Number CDS981237F ; 3) BASIC BIOPSY TRAY , Pack Number DYNDA1217A ; 4) ONCOLOGY
Open, Classified
FCHNone listed
Aug 7, 2024American Contract Systems, Inc.
American Contract Systems Biopsy Drape Pack convenience kit
Open, Classified
FCHNone listed
Jan 26, 2024American Contract Systems, Inc.
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
Open, Classified
FCHNone listed
Aug 3, 2023MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-PACK FETOSCOPY, Model Number: DYNJ906905B; b. FETOSCOPY CDS-LF, Model Number:
Open, Classified
FCHNone listed
Jul 20, 2023MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETOSCOPY CDS-LF, Model Number CDS840215O; b) US BREAST BIOPSY TRAY, Model Number DYNDH1187A; c) PACK,FET
Open, Classified
FCHNone listed
Feb 23, 2023MEDLINE INDUSTRIES, LP - Northfield
Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN N
Open, Classified
FCHNone listed
Feb 6, 2023MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
Open, Classified
FCHNone listed
Feb 22, 2022Busse Hospital Disposables, Inc.
Core Biopsy Tray Catalog Number: 8673R4
Terminated
FCHNone listed
Feb 22, 2022Busse Hospital Disposables, Inc.
Stereo Breast Biopsy Tray Catalog Number: 2383R1
Terminated
FCHNone listed
Nov 15, 2016Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
Terminated
FCHNone listed
Sep 20, 2016Custom Medical Specialties, Inc.
CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
Open, Classified
FCHNone listed
Feb 7, 2013Custom Healthcare Systems, Inc.
Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by phys
Terminated
FCHNone listed
Feb 7, 2013Custom Healthcare Systems, Inc.
Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a
Terminated
FCHNone listed

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