TIDAL DISTENSION IRRIGATION SET— 510(k) K841362

Clearance details

Applicant

Abbott Laboratories

Product code

Code GBX

Device class

Class 1

Regulation

21 CFR 878.4200

Advisory panel

General, Plastic Surgery

Date received

1984-04-02

Decision date

1984-08-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Abbott Park, IL, US

• K131659 — MOERAE VEIN PREPARATION KIT2014-03-03
• K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE2008-12-17
• K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN2005-10-21
• K043515 — GRAFTSAVER2005-03-31
• K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P2002-01-10

• K252424 — Anti-HCV Next2026-04-28
• K243500 — ARCHITECT iGentamicin2025-07-09
• K243168 — Alinity i Rubella IgG2025-06-20
• K243283 — Alinity h-series System2025-02-20
• K233932 — Alinity i Toxo IgM2024-08-30

Death

16

Injury

583

Malfunction

3,578

Other

1

Total

4,178

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1627-2014 — LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira Product Usage: For Transurethral Resection ProceduresClass II·Terminated·Hospira Inc.·20140325

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K841362.