STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE
FDA 510(k) clearance K962205 · decided 1996-11-26
Clearance details
- K-number
- K962205
- Device name
- STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE
- Applicant
- Medline Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-06-07
- Decision date
- 1996-11-26
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- KKX
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mundelein, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CU recall (Z-2124-2026) | Medline Industries, LP | 2026-05-07 |
| Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) ME recall (Z-3037-2024) | MEDLINE INDUSTRIES, LP - Northfield | 2024-09-06 |
| Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0 recall (Z-1125-2023) | MEDLINE INDUSTRIES, LP - Northfield | 2023-02-10 |
| Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per case recall (Z-0114-04) | Medline Industries Inc | 2003-11-13 |