STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE— 510(k) K962205
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K962205 for STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE, Substantially Equivalent on 1996-11-26. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code KKX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mundelein, IL, US
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Recalls naming K962205
K-number listed on FDA's recall record- Z-3037-2024 — Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4) PACEMAKER DRAPE PACK-LF , Pack Number DYNJ0406118K ; 5) FEMORAL ANGIOGRAPHY PACK, Pack Number DYNJ0618509F ; 6) EP DRAPE PACK-LF, Pack Number DYNJ22911I ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ36314J ; 8) SPLIT DRAPE , Pack Number DYNJ37265F ; 9) 4 DRAPE PROCEDURE PACK, Pack Number DYNJ39689D ; 10) DR MOTT DRAPE PACK, Pack Number DYNJ42065B ; 11) PK, EP LAB, Pack Number DYNJ43815C ; 12) MAYO STAND PACK , Pack Number DYNJ50738; 13) DAA BI-LAT, Pack Number DYNJ903538C; 14) PACEMAKER , Pack Number DYNJ903545C; 15) CSTM NEONATAL FEM DRAPE PK, Pack Number DYNJCD0114
- Z-1125-2023 — Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K962205.
Data sourced from openFDA. This site is unofficial and independent of the FDA.