KXF · Applicator, Absorbent Tipped, Non-Sterile
General Hospital · 21 CFR 880.6025 · Class 1
Overview
| Product Code | KXF |
|---|---|
| Device Name | Applicator, Absorbent Tipped, Non-Sterile |
| Regulation | 21 CFR 880.6025 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
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 (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K123184 | FINN CHAMBERS AQUA | Smartpractice | Dec 19, 2012 | SESE |
| K103409 | ALLERGEAZE R CLEAR | Smartpractice | Mar 15, 2011 | SESE |
| K063160 | ALLERGEAZE PATCH TEST CHAMBERS | Smartpractice | Dec 22, 2006 | SESE |
| K013820 | FINN CHAMBER (R) | Epitest Ltd. OY | Jan 30, 2002 | SESE |
| K992553 | IQ CHAMBERS | Dormer Laboratories, Inc. | Apr 12, 2000 | SESE |
| K870762 | EAR APPLICATOR, CATALOG NO. 2229 | Treace Medical, Inc. | Mar 6, 1987 | SESE |
| K843720 | COTTON TIPPED APPLICATORS, SINGLE | Abco Dealers, Inc. | Oct 4, 1984 | SESE |
| K820962 | COTTON SWABS | Dafoe & Dafoe, Inc. | Apr 20, 1982 | SESE |
| K813506 | FARRORS TMJ CASSETTE HOLDER | Brell Mar Products, Inc. | Jan 29, 1982 | SESE |
| K811365 | HILL TOP CHAMBER | Hill Top Research, Inc. | Aug 20, 1981 | SESE |
| K802580 | SUBCLAVIAN CATHETER INSERTION TRAY | American Pharmaseal Div. Ahsc | Nov 12, 1980 | SESE |
| K802016 | EYE APPLICATORS CAT.#980-983 | Pollak (Intl.), Ltd. | Sep 16, 1980 | SESE |
| K802020 | PREP SET CAT.#908 | Pollak (Intl.), Ltd. | Sep 9, 1980 | SESE |
| K791169 | DEXIDE DISPOSABLE SWAB STICK | Dexide, Inc. | Jul 30, 1979 | SESE |
| K791168 | DEXIDE DISPOSABLE PREP STICK | Dexide, Inc. | Jul 30, 1979 | SESE |
| K780929 | COTTON TIPPED POINT | Young Dental Manufacturing Co. 1, LLC | Jun 30, 1978 | SESE |
| K780604 | SHAVE PREP | Abco Dealers, Inc. | Apr 19, 1978 | SESE |
| K772298 | SEXUAL ASSAULT FORENCIC EVIDENCE KIT | Simpson/Basye, Inc. | Mar 2, 1978 | SESE |
| K772227 | CATH KIT, SUPERPUBIC | American Hospital Supply Corp. | Dec 20, 1977 | SESE |
| K770583 | MEDI-PAK LEMON GLYCEOIN SWABS | General Medical Co. | May 26, 1977 | SESE |
Top Applicants
- Smartpractice — 3 clearances
- Abco Dealers, Inc. — 2 clearances
- Dexide, Inc. — 2 clearances
- Pollak (Intl.), Ltd. — 2 clearances
- American Hospital Supply Corp. — 1 clearance
