510(k) K083234 ยท KKX Drape, Surgical, Antimicrobial
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100
| Applicant | Kimberly-Clark Corp., Dawsonville GA, US |
| Decision | Substantially Equivalent, Mar 25, 2009 |
| Received | Nov 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083234
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2025 | O&M HALYARD INC Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029
Universal Pack, Model: 77165-06 AC2424902B 09/05/2029 Open, Classified |
KKX | None listed |
| Jan 17, 2025 | O&M HALYARD, INC. Brand Name: HALYARD
Product Name: Laparotomy Pack
Model/Catalog Number: 88231
Software Version: N/A
Product Description: Laparotomy Pack
Component: N/A Open, Classified |
KKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.