STERILE FIELD SALINE PRE-FILLED SYRINGE(S)— 510(k) K082837

Clearance details

Applicant

Excelsior Medical Corp.

Product code

Code NGT

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2008-09-26

Decision date

2008-12-18

Decision

Substantially Equivalent

Clearance type

Special

Location

Neptune, NJ, US

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• K223584 — Pre-Filled Normal Saline Flush Syringe2023-08-12

• K130975 — SWABCAP AND SWABFLUSH2013-12-24
• K101270 — SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 103112011-02-10
• K083508 — SWABCAP2009-04-28
• K061497 — SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML2007-02-23
• K053120 — STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES2005-12-09

Death

12

Malfunction

2,008

Other

4

Total

2,024

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-0898-2022 — Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.Class II·Terminated·MEDLINE INDUSTRIES, LP - Northfield·20220304

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082837.