FOB · Bedpan
General Hospital · 21 CFR 880.6730 · Class 1
Overview
| Product Code | FOB |
|---|---|
| Device Name | Bedpan |
| Regulation | 21 CFR 880.6730 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.
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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K791346 | DISPOSABLE BEDPAN | General Clinical Plastics Corp. | Aug 3, 1979 | SESE |
| K780370 | STAND UP TOILET | Medical Specialty Products, Inc. | Apr 10, 1978 | SESE |
| K760490 | BEDPAN, GENERAL MEDICAL MEDI-PAK | Landmark Plastics | Nov 12, 1976 | SESE |
| K760393 | BED PAN, STACKABLE (AUTOCLAVABLE) | Bemis Health Care | Aug 23, 1976 | SESE |
| K760307 | BEDPAN, SINGLE PATIENT USE, TECNOL | Tecnol New Jersey Wound Care, Inc. | Aug 11, 1976 | SESE |
Top Applicants
- Bemis Health Care — 1 clearance
- General Clinical Plastics Corp. — 1 clearance
- Landmark Plastics — 1 clearance
- Medical Specialty Products, Inc. — 1 clearance
- Tecnol New Jersey Wound Care, Inc. — 1 clearance
