Scale, Sponge, Surgical, Electrically-Powered
The Electrically-Powered Surgical Sponge Scale is a general hospital device used in the operating room to weigh blood-soaked surgical sponges, enabling accurate estimation of intraoperative blood loss to guide transfusion decisions. Classified as FDA Class 1 under 21 CFR 880.2740 in the General Hospital specialty, it is 510(k)-exempt and subject only to general controls. The product code is MRL.
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Basic Information
- Product Code
- MRL
- 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 |
|---|---|---|---|---|
| K964181 | SPONGETRAC | Feb 26, 1997 | Substantially Equivalent | Surgitrac Corp. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.