KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100— 510(k) K083234
Substantially EquivalentKimberly-Clark Corp.
FDA 510(k) clearance K083234 for KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100, Substantially Equivalent on 2009-03-25. Applicant: Kimberly-Clark Corp.. Device class: 2.
Clearance details
- Applicant
- Kimberly-Clark Corp.
- 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
- Dawsonville, GA, US
Recent devices under product code KKX
view allMore clearances from Kimberly-Clark Corp.
view allRecalls naming K083234
K-number listed on FDA's recall record- Z-2520-2025 — Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
- Z-0983-2025 — Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083234.
Data sourced from openFDA. This site is unofficial and independent of the FDA.