MEDLINE NEURO SPONGE— 510(k) K140369
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K140369 for MEDLINE NEURO SPONGE, Substantially Equivalent on 2014-09-26. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code HBA
- Device class
- Class 2
- Regulation
- 21 CFR 882.4700
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mundelein, IL, US
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Recalls naming K140369
K-number listed on FDA's recall record- Z-2008-2026 — Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Medline SKU NEUROSPNG02; 2. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 0.5", XR, 10/PK, Medline SKU NEUROSPNG05; 3. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 1", XR, LF, 10/PK, Medline SKU NEUROSPNG06; 4. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 1.5", XR, LF, 10/PK, Medline SKU NEUROSPNG07; 5. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 3", XR, LF, 10/PK, Medline SKU NEUROSPNG09; 6. Neuro Sponges, Eponges neuro, Neuroesponjas, size .75" X .75", XR, LF, 10/PK, Medline SKU NEUROSPNG11; 7. Neuro Sponges, Eponges neuro, Neuroesponjas, size 1" X 1", XR, LF, 10/PK, Medline SKU NEUROSPNG13; 8. Neuro Sponges, Eponges neuro, Neuroesponjas, size 1" X 3", XR, LF, 10/PK, Medline SKU NEUROSPNG14.
- Z-2032-2026 — Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC38133
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140369.
Data sourced from openFDA. This site is unofficial and independent of the FDA.