BXJ · Clip, Nose
Anesthesiology · 21 CFR 868.6225 · Class 1
Overview
| Product Code | BXJ |
|---|---|
| Device Name | Clip, Nose |
| Regulation | 21 CFR 868.6225 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
| GMP Exempt | Yes |
Identification
A nose clip is a device intended to close a patient's external nares (nostrils) during diagnostic or therapeutic procedures.
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 § 868.9. The device is also 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.
Cleared Devices (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K853578 | MEDIPART DISPOS. NOSE CLIP MP-2001 | Medipart Jerry Alexander | Oct 29, 1985 | SESE |
| K810339 | NOSECLIP #6118 | Todd Industries, Inc. | Mar 17, 1981 | SESE |
| K770015 | NOSECLIP FOR RESP. CARE & PULMON. FUNC. | Bd Becton Dickinson Vacutainer Systems Preanalytic | Mar 16, 1977 | SESE |
| K760461 | NOSE CLIP | Inspiron Corp. | Aug 26, 1976 | SESE |
Top Applicants
- Todd Industries, Inc. — 1 clearance
- Medipart Jerry Alexander — 1 clearance
- Inspiron Corp. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
