FQA · Scale, Surgical Sponge
General Hospital · 21 CFR 880.2740 · Class 1
Overview
| Product Code | FQA |
|---|---|
| Device Name | Scale, Surgical Sponge |
| Regulation | 21 CFR 880.2740 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K830273 | COUNTWAY SYS. SOILED SPONGES-BLOOD LOS | Ritmed, Inc. | Feb 28, 1983 | SESE |
Top Applicants
- Ritmed, Inc. — 1 clearance
