KXG · Applicator, Absorbent Tipped, Sterile
General Hospital · 21 CFR 880.6025 · Class 1
Overview
| Product Code | KXG |
|---|---|
| Device Name | Applicator, Absorbent Tipped, Sterile |
| Regulation | 21 CFR 880.6025 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a 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. If the device is not labeled or otherwise represented as sterile, it 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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K802004 | PROFILE SWAB CAT.#5273 & 5274 | Pollak (Intl.), Ltd. | Sep 16, 1980 | SESE |
Top Applicants
- Pollak (Intl.), Ltd. — 1 clearance
