DYNAREX STERILE LUBRICATING JELLY— 510(k) K092488

Name: FDA 510(k) clearance K092488
Creator: U.S. Food and Drug Administration
Published: 2009-12-18

Substantially Equivalent

Dynarex Corporation

FDA 510(k) clearance K092488 for DYNAREX STERILE LUBRICATING JELLY, Substantially Equivalent on 2009-12-18. Applicant: Dynarex Corporation. Device class: 1.

Clearance details

Applicant: Dynarex Corporation
Product code: Code KMJ
Device class: Class 1
Regulation: 21 CFR 880.6375
Advisory panel: General Hospital
Date received: 2009-08-13
Decision date: 2009-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMJ

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K142473 — Lubricating Jelly2015-04-13
K141028 — COLONGLIDE LUBRICANT2014-07-24
K131617 — COLONGLIDE(R) LUBRICANT2013-10-03
K121390 — LUBE JELLY SURINGE2012-08-10
K113689 — DUKAL LUBRICATING JELLY2012-05-04

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K103086 — DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC2011-06-07
K102637 — DYNAREX ULTRASOUND GEL2011-02-16

Recalls naming K092488

K-number listed on FDA's recall record

Z-1635-2022 — DYNAREX DynaLube LUBRICATING JELLY, STR 2.7GM (144/BX 12BX/CS) Catalog #1250Class II·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·20220525

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092488.

Data sourced from openFDA. This site is unofficial and independent of the FDA.