Applicator, Absorbent Tipped, Non-Sterile
The Non-Sterile Absorbent Tipped Applicator is a general-purpose medical applicator with an absorbent tip, such as cotton or foam, used for applying medications, cleansing wounds, or collecting specimens in a non-sterile configuration. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, and is exempt from Good Manufacturing Practice (GMP) requirements. The product code is KXF, regulated under 21 CFR 880.6025, in the General Hospital medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- KXF
- Device Class
- FDA class 1
- Regulation Number
- 880.6025
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 21 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K123184 | FINN CHAMBERS AQUA | Dec 19, 2012 | Substantially Equivalent | Smartpractice |
| K103409 | ALLERGEAZE R CLEAR | Mar 15, 2011 | Substantially Equivalent | Smartpractice |
| K063160 | ALLERGEAZE PATCH TEST CHAMBERS | Dec 22, 2006 | Substantially Equivalent | Smartpractice |
| K013820 | FINN CHAMBER (R) | Jan 30, 2002 | Substantially Equivalent | Epitest Ltd. OY |
| K992553 | IQ CHAMBERS | Apr 12, 2000 | Substantially Equivalent | Dormer Laboratories, Inc. |
| K870762 | EAR APPLICATOR, CATALOG NO. 2229 | Mar 06, 1987 | Substantially Equivalent | Treace Medical, Inc. |
| K843720 | COTTON TIPPED APPLICATORS, SINGLE | Oct 04, 1984 | Substantially Equivalent | Abco Dealers, Inc. |
| K820962 | COTTON SWABS | Apr 20, 1982 | Substantially Equivalent | Dafoe & Dafoe, Inc. |
| K813506 | FARRORS TMJ CASSETTE HOLDER | Jan 29, 1982 | Substantially Equivalent | Brell Mar Products, Inc. |
| K811365 | HILL TOP CHAMBER | Aug 20, 1981 | Substantially Equivalent | Hill Top Research, Inc. |
| K802580 | SUBCLAVIAN CATHETER INSERTION TRAY | Nov 12, 1980 | Substantially Equivalent | American Pharmaseal Div. Ahsc |
| K802016 | EYE APPLICATORS CAT.#980-983 | Sep 16, 1980 | Substantially Equivalent | Pollak (Intl.), Ltd. |
| K802020 | PREP SET CAT.#908 | Sep 09, 1980 | Substantially Equivalent | Pollak (Intl.), Ltd. |
| K791169 | DEXIDE DISPOSABLE SWAB STICK | Jul 30, 1979 | Substantially Equivalent | Dexide, Inc. |
| K791168 | DEXIDE DISPOSABLE PREP STICK | Jul 30, 1979 | Substantially Equivalent | Dexide, Inc. |
| K780929 | COTTON TIPPED POINT | Jun 30, 1978 | Substantially Equivalent | Young Dental Manufacturing Co. 1, LLC |
| K780604 | SHAVE PREP | Apr 19, 1978 | Substantially Equivalent | Abco Dealers, Inc. |
| K772298 | SEXUAL ASSAULT FORENCIC EVIDENCE KIT | Mar 02, 1978 | Substantially Equivalent | Simpson/Basye, Inc. |
| K772227 | CATH KIT, SUPERPUBIC | Dec 20, 1977 | Substantially Equivalent | American Hospital Supply Corp. |
| K770583 | MEDI-PAK LEMON GLYCEOIN SWABS | May 26, 1977 | Substantially Equivalent | General Medical Co. |
| K770433 | Q-TIPS | Apr 15, 1977 | Substantially Equivalent | Chesebrough-Pond'S U.S.A. Co. |
FEI Numbers
This FDA classification entry is associated with 364 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 364 registration numbers. Click on an entry to view related FDA registrations.