SURGICOUNT SAFETY-SPONGE SYSTEM— 510(k) K060076
Substantially EquivalentSurgicount Medical
FDA 510(k) clearance K060076 for SURGICOUNT SAFETY-SPONGE SYSTEM, Substantially Equivalent on 2006-03-14. Applicant: Surgicount Medical. Device class: 1.
Clearance details
- Applicant
- Surgicount Medical
- Product code
- Code LWH
- Device class
- Class 1
- Regulation
- 21 CFR 880.2740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yorba Linda, CA, US
Recent devices under product code LWH
view allRecalls naming K060076
K-number listed on FDA's recall record- Z-1452-2022 — SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
- Z-1379-2016 — SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges, and towels used during surgical procedures.
- Z-0986-2015 — The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount Safety-Sponge System. The SurgiCount Safety-Sponge System is indicated for use in counting and recording the number of Safety-Sponge surgical sponges, laparotomy sponges, and towels used during surgical procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060076.
Data sourced from openFDA. This site is unofficial and independent of the FDA.