CROSSTEX NON-WOVEN SPONGES— 510(k) K984187

Name: FDA 510(k) clearance K984187
Creator: U.S. Food and Drug Administration
Published: 1999-02-18

Substantially Equivalent

Crosstex Intl.

FDA 510(k) clearance K984187 for CROSSTEX NON-WOVEN SPONGES, Substantially Equivalent on 1999-02-18. Applicant: Crosstex Intl.. Device class: Unclassified.

Clearance details

Applicant: Crosstex Intl.
Product code: Code EFQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1998-11-23
Decision date: 1999-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck,, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFQ

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K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE1999-08-12
K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S1999-06-11
K990974 — VITOP DRESSING1999-06-09
K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE1999-04-23
K983016 — GAUZE, SPONGES, CAT # 11-0031999-02-12

More clearances from Crosstex Intl.

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K012602 — CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX2002-01-22

Recalls naming K984187

K-number listed on FDA's recall record

Z-1118-2022 — Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100Class II·Terminated·Steris Corporation·20220322
Z-1119-2022 — Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100Class II·Terminated·Steris Corporation·20220322

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K984187.

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