Product code FRL
- Device name
- Fiber, Medical, Absorbent
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.5300
- 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 |
|---|---|---|---|
| K121898 | STAY FRESH SKIN FOLD MANAGEMENT TEXTILE | Quick-Med Technologies, Inc. | 2013-05-24 |
| K110715 | INTERDRY SILVER | Milliken Healthcare Products, LLC | 2011-11-04 |
| K061615 | INTERDRY TEXTILE WITH SILVER | Milliken Chemical | 2006-12-22 |
| K931626 | CARAPACE STERILE COTTON BALLS | Carapace, Inc. | 1993-12-02 |
| K914081 | ICAN COTTON RAYON BALLS | Icn Pharmaceuticals, Inc. | 1991-10-09 |
| K811990 | TRACH CLEANING TRAY | Associated Medical Products Co. | 1981-07-27 |
| K810242 | UTENSIL & PROCEDURE TRAYS | American Hospital Supply Corp. | 1981-04-15 |
| K800277 | MEDSPEC RAYON BALLS | Medspec Corp. | 1980-03-12 |
| K800248 | SURGITEK FOERSTER FACE LIFT BANDAGE | Medical Engineering Corp. | 1980-02-19 |
| K800249 | SURGITEK FOERSTER MAMMARY BANDAGE | Medical Engineering Corp. | 1980-02-19 |
| K792295 | SORBIES | American Hospital Supply Corp. | 1979-12-20 |
| K792294 | BREAST PAD | American Hospital Supply Corp. | 1979-12-11 |
| K791167 | DEXIDE DISPOSABLE PREP PAD | Dexide, Inc. | 1979-08-03 |
| K780974 | BACILLUS PUMILUS | Urol, Inc. | 1978-07-27 |
| K771712 | CATHETER DRESSING CHANCE SET | Shield Laboratories, Inc. | 1977-10-13 |
| K771551 | I.V. PREP & CARE KIT | Jelco Laboratories | 1977-10-04 |
| K770588 | COTTON BALL KIT | American Hospital Supply Corp. | 1977-05-23 |
| K770853 | STERILE COTTON | Stat Medical Corp. | 1977-05-23 |
| K761099 | DOVER HYPERALIMENTATION DRESSING CHNG KT | Will Ross Co. | 1977-01-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20197344219503 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-07-17 |
| 20197344219497 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-07-17 |
| 20197344219480 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-07-17 |
| 20197344219473 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-07-17 |
| 20197344219466 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-07-17 |
| 20197344219459 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-07-17 |
| 20197344219442 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-07-17 |
| 20197344219428 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-07-17 |
| 20197344219435 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-07-13 |
| 00653160232196 | CENTURION | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-01 |
| 00885380173878 | Curity | Cardinal Health, Inc. | 2020-10-23 |
| 00885380173908 | Curity | Cardinal Health, Inc. | 2020-10-23 |
| 00885380173892 | Curity | Cardinal Health, Inc. | 2020-10-23 |
| 20885380174886 | Curity | Cardinal Health, Inc. | 2019-11-14 |
| 20885380174671 | Curity | Cardinal Health, Inc. | 2019-11-14 |
| 20885380173544 | Curity | Cardinal Health, Inc. | 2019-11-14 |
| 10885380173691 | Curity | Cardinal Health, Inc. | 2019-11-14 |
| 20885380173537 | Curity | Cardinal Health, Inc. | 2019-11-14 |
| 20885380173568 | Curity | Cardinal Health, Inc. | 2019-11-14 |
| 20885380174473 | Curity | Cardinal Health, Inc. | 2019-11-14 |
| 20885380174480 | Curity | Cardinal Health, Inc. | 2019-11-14 |
| 20885380174558 | Curity | Cardinal Health, Inc. | 2019-11-14 |
| 20885380174626 | Curity | Cardinal Health, Inc. | 2019-11-14 |
| 20885380174633 | Curity | Cardinal Health, Inc. | 2019-11-14 |
| 20885380174657 | Curity | Cardinal Health, Inc. | 2019-11-14 |
| 20885380174664 | Curity | Cardinal Health, Inc. | 2019-11-14 |
| 20885380174688 | Curity | Cardinal Health, Inc. | 2019-11-14 |
| 10884521082403 | Curity | Cardinal Health, Inc. | 2018-06-29 |
| 10884521084216 | Kerlix | Cardinal Health, Inc. | 2018-06-29 |
| 10884527020782 | Curity | Cardinal Health, Inc. | 2018-06-29 |