Product code KXF
- Device name
- Applicator, Absorbent Tipped, Non-Sterile
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.6025
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123184 | FINN CHAMBERS AQUA | Smartpractice | 2012-12-19 |
| K103409 | ALLERGEAZE R CLEAR | Smartpractice | 2011-03-15 |
| K063160 | ALLERGEAZE PATCH TEST CHAMBERS | Smartpractice | 2006-12-22 |
| K013820 | FINN CHAMBER (R) | Epitest Ltd. OY | 2002-01-30 |
| K992553 | IQ CHAMBERS | Dormer Laboratories, Inc. | 2000-04-12 |
| K870762 | EAR APPLICATOR, CATALOG NO. 2229 | Treace Medical, Inc. | 1987-03-06 |
| K843720 | COTTON TIPPED APPLICATORS, SINGLE | Abco Dealers, Inc. | 1984-10-04 |
| K820962 | COTTON SWABS | Dafoe & Dafoe, Inc. | 1982-04-20 |
| K813506 | FARRORS TMJ CASSETTE HOLDER | Brell Mar Products, Inc. | 1982-01-29 |
| K811365 | HILL TOP CHAMBER | Hill Top Research, Inc. | 1981-08-20 |
| K802580 | SUBCLAVIAN CATHETER INSERTION TRAY | American Pharmaseal Div. Ahsc | 1980-11-12 |
| K802016 | EYE APPLICATORS CAT.#980-983 | Pollak (Intl.), Ltd. | 1980-09-16 |
| K802020 | PREP SET CAT.#908 | Pollak (Intl.), Ltd. | 1980-09-09 |
| K791168 | DEXIDE DISPOSABLE PREP STICK | Dexide, Inc. | 1979-07-30 |
| K791169 | DEXIDE DISPOSABLE SWAB STICK | Dexide, Inc. | 1979-07-30 |
| K780929 | COTTON TIPPED POINT | Young Dental Manufacturing Co. 1, LLC | 1978-06-30 |
| K780604 | SHAVE PREP | Abco Dealers, Inc. | 1978-04-19 |
| K772298 | SEXUAL ASSAULT FORENCIC EVIDENCE KIT | Simpson/Basye, Inc. | 1978-03-02 |
| K772227 | CATH KIT, SUPERPUBIC | American Hospital Supply Corp. | 1977-12-20 |
| K770583 | MEDI-PAK LEMON GLYCEOIN SWABS | General Medical Co. | 1977-05-26 |
| K770433 | Q-TIPS | Chesebrough-Pond'S U.S.A. Co. | 1977-04-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327680737 | Q-Care | SAGE PRODUCTS, LLC | 2025-12-03 |
| 07613327680744 | Q-Care | SAGE PRODUCTS, LLC | 2025-12-03 |
| 07613327680751 | Q-Care | SAGE PRODUCTS, LLC | 2025-12-03 |
| 07613327680720 | Q-Care | SAGE PRODUCTS, LLC | 2025-12-03 |
| M220761002 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2025-09-11 |
| 10840330701485 | ProCure | Twin Med, LLC | 2024-11-14 |
| 10840330701478 | ProCure | Twin Med, LLC | 2024-11-14 |
| 10840330701461 | ProCure | Twin Med, LLC | 2024-11-14 |
| 10840330701454 | ProCure | Twin Med, LLC | 2024-11-14 |
| 10817522013343 | Swabeze | KENTEC MEDICAL, INC. | 2024-06-20 |
| 10732224003525 | Premium Cotton Tipped Applicators | CROSSTEX INTERNATIONAL, INC. | 2022-08-19 |
| 10732224003556 | Advantage Plus Cotton Tipped Applicators | CROSSTEX INTERNATIONAL, INC. | 2022-08-19 |
| 10732224003549 | Advantage Plus Cotton Tipped Applicators | CROSSTEX INTERNATIONAL, INC. | 2022-08-19 |
| 10732224003532 | Premium Cotton Tipped Applicators | CROSSTEX INTERNATIONAL, INC. | 2022-08-19 |
| 10885380179891 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-08-30 |
| 10884389105641 | Medline | MEDLINE INDUSTRIES, INC. | 2020-11-17 |
| 10686864053825 | MEDICOM SAFEBASICS | AMD Medicom Inc | 2019-01-14 |
| 10686864049699 | MEDICOM SAFEBASICS | AMD Medicom Inc | 2019-01-14 |
| 10686864049088 | AMD-RITMED SOLON | AMD Medicom Inc | 2019-01-14 |
| 10686864049071 | AMD-RITMED SOLON | AMD Medicom Inc | 2019-01-14 |
| 10686864049064 | AMD-RITMED SOLON | AMD Medicom Inc | 2019-01-14 |
| 10686864049057 | AMD-RITMED SOLON | AMD Medicom Inc | 2019-01-14 |
| 10686864049040 | AMD-RITMED SOLON | AMD Medicom Inc | 2019-01-14 |
| 10686864046070 | AMD-RITMED SOLON | AMD Medicom Inc | 2019-01-14 |
| 10686864046032 | AMD-RITMED SOLON | AMD Medicom Inc | 2019-01-14 |
| 10686864045998 | AMD-RITMED SOLON | AMD Medicom Inc | 2019-01-14 |
| 10885425281831 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-19 |
| 10885425323456 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-08-17 |
| 10885425281855 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-08-01 |
| 10885425323500 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-07-27 |