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)
Top companies in FCH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2025 | American Contract Systems Inc. Basic Biopsy Tray, Item Number NMBP44L Open, Classified |
FCH | None listed |
| Sep 6, 2024 | MEDLINE 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 |
FCH | None listed |
| Aug 7, 2024 | American Contract Systems, Inc. American Contract Systems Biopsy Drape Pack convenience kit Open, Classified |
FCH | None listed |
| Jan 26, 2024 | American Contract Systems, Inc. Custom procedural convenience kits and trays, gastroenterological & urological, labeled as:
AHN BIOPSY STERILE, kit number AHBP12A Open, Classified |
FCH | None listed |
| Aug 3, 2023 | MEDLINE 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 |
FCH | None listed |
| Jul 20, 2023 | MEDLINE 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 |
FCH | None listed |
| Feb 23, 2023 | MEDLINE 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 |
FCH | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following:
a. MINOR/BREAST BIOPSY-LF
b. BREAST BIOPSY-LF Open, Classified |
FCH | None listed |
| Feb 22, 2022 | Busse Hospital Disposables, Inc. Core Biopsy Tray
Catalog Number: 8673R4 Terminated |
FCH | None listed |
| Feb 22, 2022 | Busse Hospital Disposables, Inc. Stereo Breast Biopsy Tray
Catalog Number: 2383R1 Terminated |
FCH | None listed |
| Nov 15, 2016 | Robert 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 |
FCH | None listed |
| Sep 20, 2016 | Custom 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 |
FCH | None listed |
| Feb 7, 2013 | Custom 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 |
FCH | None listed |
| Feb 7, 2013 | Custom 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 |
FCH | None listed |
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