Panels › Gastroenterology, Urology › Product code NWU · Class 2
Endoscope Introducer Kit
Regulation 876.1500
0510(k)s in 12 months (3 all time)
3recalls in 12 months (25 all time)
0recalls that name a 510(k)
Top companies in NWU
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Cardinal Health 200, LLC Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:
1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU;
2) KIT,GU DAVINCI , Catalog Number: PGVMDVBWV;
3) KI Open, Classified |
NWU | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT,ROBOTICS DH , Catalog Number: PGOCRDNHD;
2) KIT, EAS ROBOTIC , Catalog Number: Open, Classified |
NWU | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:
1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J;
2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Numb Open, Classified |
NWU | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
BUCY78E CYSTO PACK
CMCP10X CYSTO PACK - 205972
IHCY10Y CYSTO PACK
MHCY35AE CYSTO PACK- 212487
PLBY52E CYSTO PACK
UDCY31Z CYSTO PACK - 206047
UICY28L Open, Classified |
NWU | None listed |
| Aug 28, 2025 | American Contract Systems Inc AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) CYSTO, Model/Item Number ASCY24A;
2) CYSTO PACK, Model/Item Number BUCY78E;
3) CYSTO PACK, Model/Item Number LMCP22T;
4) Open, Classified |
NWU | None listed |
| Mar 25, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G Open, Classified |
NWU | None listed |
| Mar 21, 2025 | American Contract Systems, Inc. Brand Name: Banner Health Systems
Product Name: Cysto Pack
Model/Catalog Number: BHCY31E
Product Description: Convenience Kit
Component: No Open, Classified |
NWU | None listed |
| Mar 14, 2025 | American Contract Systems Inc CYSTO
, Model No SACY80R Open, Classified |
NWU | None listed |
| Mar 14, 2025 | American Contract Systems Inc CYSTO PACK
, Model N. HKCY31A Open, Classified |
NWU | None listed |
| Feb 10, 2025 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA;
2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB;
3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC Open, Classified |
NWU | None listed |
| Jan 15, 2025 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:;
2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:;
3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:;
4 ) Open, Classified |
NWU | None listed |
| Dec 30, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline custom medical procedure kits labeled as:
1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B;
2) ENDOSCOPIC SKULL BASE, REF DYNJ58648C;
3) ENT ENDO SINUS WILMINGTON PACK, REF DYNJ66447;
4) ENDOSCOP Open, Classified |
NWU | None listed |
| Dec 5, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE convenience kits labeled as:
1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G;
2) ENDO BLADDER PACK, REF DYNJ49672L Open, Classified |
NWU | None listed |
| Sep 24, 2024 | American Contract Systems, Inc. Cysto, FTCY03L; Medical convenience kit Open, Classified |
NWU | None listed |
| Sep 11, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline convenience kits containing semi-rigid suction liners labeled as follows:
a) ENDO BRONCH PACK, Pack Number DYKE1355;
b) ENDO BASIC KIT, Pack Number DYKE1356;
c) ENDOSCOPY KIT, Pack Number DY Open, Classified |
NWU | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ;
2) GB GENERAL ENDO , Pack Number CDS984155F ;
3) ENDOSCOPY KIT , Pack Number DYKE1112 ;
4) ENDOSCOPY KIT , Pac Open, Classified |
NWU | None listed |
| Aug 22, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline medical procedure kits labeled as follows:
a) ENDO KIT, REF DYK1012268E1 Open, Classified |
NWU | None listed |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B
An endoscope and ac Open, Classified |
NWU | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE Kits, trays, and packs labeled as follows:
a) C-SECTION, REF DYNJ904653G;
b) DRESSING TRAY, REF M101426;
c) ENDO KIT, REF DYKE1387;
d) ENDO KIT, REF DYKE1364B;
e) ENDO KIT, REF DYKE1892; Open, Classified |
NWU | None listed |
| Oct 26, 2023 | American Contract Systems, Inc. Cath Cardiac Pack, REF IHCC03V Open, Classified |
NWU | None listed |
| Oct 26, 2023 | American Contract Systems, Inc. Pediatric Urology Wolson Pack, REF BPPU55A Open, Classified |
NWU | 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. PACK ENDO AAA HYBRID CHRG, Model Number: DYNJ60126B; Open, Classified |
NWU | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126B Open, Classified |
NWU | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY Open, Classified |
NWU | None listed |
| Jun 16, 2022 | American Contract Systems, Inc. Various Cysto Packs Open, Classified |
NWU | None listed |
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