Endoscope Introducer Kit
FDA product code NWU · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
3510(k) clearances
0PMA approvals
24recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933268 | Candela GuidewireNWU · Traditional | Candela Laser Corp. | 02/10/1994SE |
| K874045 | Pharmaseal Endoscopy Prep Kit Upper and LowerNWU · Traditional | American Pharmaseal Div. Ahsc | 12/03/1987SE |
| K813332 | Bristol Ballon Introducer, Mandril SetNWU · Traditional | Inmed Corp. | 12/14/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3097-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | Cardinal Health 200, LLC | 07/29/2026Open, Classified |
| Z-2023-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | Medline Industries, LP | 03/19/2026Open, Classified |
| Z-0174-2026 Class II | Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK -…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | American Contract Systems Inc. | 09/04/2025Open, Classified |
| Z-2466-2025 Class II | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO…During an internal investigation, ACS determined that the rationale for sterilization of certain components… | American Contract Systems Inc | 07/14/2025Open, Classified |
| Z-1442-2025 Class II | Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673GMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 02/11/2025Open, Classified |
| Z-1346-2025 Class II | CYSTO , Model No SACY80RACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | American Contract Systems Inc | 02/06/2025Open, Classified |
| Z-1335-2025 Class II | CYSTO PACK , Model N. HKCY31AACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | American Contract Systems Inc | 02/06/2025Open, Classified |
| Z-1424-2025 Class II | Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E…Sterility assurance with procedure trays | American Contract Systems, Inc. | 01/31/2025Open, Classified |
| Z-0784-2025 Class II | Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | MEDLINE INDUSTRIES, LP - Northfield | 11/21/2024Open, Classified |
| Z-1128-2025 Class II | Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2)…Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Cardinal Health 200, LLC | 11/08/2024Open, Classified |
| Z-0909-2025 Class II | Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 )…Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Cardinal Health 200, LLC | 11/08/2024Open, Classified |
| Z-0631-2025 Class II | MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | MEDLINE INDUSTRIES, LP - Northfield | 10/09/2024Open, Classified |
| Z-3243-2024 Class II | Cysto, FTCY03L; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | American Contract Systems, Inc. | 08/07/2024Open, Classified |
| Z-3111-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: a)…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | MEDLINE INDUSTRIES, LP - Northfield | 06/27/2024Open, Classified |
| Z-2557-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | Merit Medical Systems, Inc. | 06/11/2024Open, Classified |
| Z-3009-2024 Class II | Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2705-2024 Class II | Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. | MEDLINE INDUSTRIES, LP - Northfield | 03/22/2024Open, Classified |
| Z-1103-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | MEDLINE INDUSTRIES, LP - Northfield | 11/15/2023Open, Classified |
| Z-0182-2024 Class II | Cath Cardiac Pack, REF IHCC03VDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | American Contract Systems, Inc. | 09/01/2023Open, Classified |
| Z-0181-2024 Class II | Pediatric Urology Wolson Pack, REF BPPU55ADuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | American Contract Systems, Inc. | 09/01/2023Open, Classified |
| Z-2174-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | MEDLINE INDUSTRIES, LP - Northfield | 05/18/2023Open, Classified |
| Z-2314-2023 Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.…Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. | MEDLINE INDUSTRIES, LP - Northfield | 05/15/2023Open, Classified |
| Z-1075-2023 Class II | Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPYSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | MEDLINE INDUSTRIES, LP - Northfield | 11/17/2022Open, Classified |
| Z-1695-2022 Class II | Various Cysto PacksProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | American Contract Systems, Inc. | 06/16/2022Open, Classified |