Scale, Surgical Sponge
The Surgical Sponge Scale is a precision weighing device used in the operating room to measure the weight of surgical sponges before and after use, enabling estimation of intraoperative blood loss by calculating fluid absorbed. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FQA, regulated under 21 CFR 880.2740 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- FQA
- Device Class
- FDA class 1
- Regulation Number
- 880.2740
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K830273 | COUNTWAY SYS. SOILED SPONGES-BLOOD LOS | Feb 28, 1983 | Substantially Equivalent | Ritmed, Inc. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.