510(k) K984187 ยท EFQ Gauze/Sponge, Internal
CROSSTEX NON-WOVEN SPONGES
| Applicant | Crosstex Intl., Great Neck, NY, US |
| Decision | Substantially Equivalent, Feb 18, 1999 |
| Received | Nov 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984187
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2022 | Steris Corporation 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: ENC100 Terminated |
EFQ | None listed |
| Mar 22, 2022 | Steris Corporation 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: ENC4100 Terminated |
EFQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.