Product code FQM
- Device name
- Bandage, Elastic
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.5075
- 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 |
|---|---|---|---|
| K040936 | PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE | Leda Co., Ltd. | 2004-05-03 |
| K040054 | BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE | Theodore Barash | 2004-04-27 |
| K013244 | COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE | Med Gen, Inc. | 2001-12-07 |
| K952738 | SKIN SAVER SYSTEMS | Skin Saver Systems, Inc. | 1995-09-29 |
| K872868 | ASPEN ESMARK BANDAGE | Aspen Laboratories, Inc. | 1987-07-31 |
| K840107 | TUBE-BANDAGE FOR HUMAN DIGITS 200 | Zens Health Care Products | 1984-04-25 |
| K831728 | MEDICALEX | Medicalex | 1984-01-09 |
| K830622 | ORTHO WRAP | Fast Wrap Co., Inc. | 1983-06-20 |
| K831551 | COMPRESSOGRIP TUBULAR ELASTIC BANDAGE | Fred Sammons, Inc. | 1983-06-07 |
| K820142 | TUBULAR STOCKINETTE | Stan-Pak Ent. | 1982-02-05 |
| K820141 | BIAS STOCKINETTE | Stan-Pak Ent. | 1982-02-05 |
| K820094 | ELASTIC BANDAGE | Stan-Pak Ent. | 1982-01-29 |
| K811173 | STRUVA & MEDI | Weco | 1981-06-18 |
| K810137 | SOF-BAND HIGH STRETCH BANDAGES | Johnson & Johnson Professionals, Inc. | 1981-02-17 |
| K802992 | ELASTIC GAUZE | Abco Dealers, Inc. | 1980-12-30 |
| K802991 | ROLL STRETCH GAUZE | Abco Dealers, Inc. | 1980-12-30 |
| K802785 | ELASTIC BANDAGE | Secol Co. | 1980-12-11 |
| K802789 | TUBULAR BANDAGE | Secol Co. | 1980-12-10 |
| K802784 | ELASTIC OPEN WEAVE BANDAGE | Secol Co. | 1980-12-10 |
| K802015 | FINGER PAINGUARD CAT.#193-194 | Pollak (Intl.), Ltd. | 1980-09-09 |
| K801990 | ELASTIC BANDAGE CAT.#182-186 (WIDTH) | Pollak (Intl.), Ltd. | 1980-09-09 |
| K801458 | WINTER HEAD DRESSING | Steridyne Corp. | 1980-07-28 |
| K801532 | STOCKINETTE, STERILE TWO PLY W/PULL TABS | The Owenby Co. | 1980-07-28 |
| K800280 | MEDSPEC RUBBER ELASTIC BANDAGES | Medspec Corp. | 1980-03-12 |
| K800197 | ANAGO DISP., ALL PURPOSE PATIENT REST. | Anago, Inc. | 1980-02-26 |
| K792331 | TOMMY TOES | Tommy Toes | 1979-12-20 |
| K792065 | POROUS ELASTIC RUBBER BANDAGE | Norman R. Sanborn Co. | 1979-11-20 |
| K791256 | SECUTEX SURGICAL BINDER | Conphar, Inc. | 1979-08-03 |
| K791211 | BINDAFIX | Conphar, Inc. | 1979-08-03 |
| K790210 | STOCKINETTE, TUBULAR UNBLEACHED | The Owenby Co. | 1979-02-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809302580676 | New Soosung Elastic Bandage | soosung medical | 2025-12-26 |
| 08809302580911 | New Soosung Elastic Bandage | soosung medical | 2025-12-26 |
| 08809302580645 | New Soosung Elastic Bandage | soosung medical | 2025-12-26 |
| 08809302580867 | New Soosung Elastic Bandage | soosung medical | 2025-12-24 |
| 08809302587217 | Soosung Elastic Bandage | soosung medical | 2025-12-11 |
| 08809302587224 | Soosung Elastic Bandage | soosung medical | 2025-12-11 |
| 08809302587231 | Soosung Elastic Bandage | soosung medical | 2025-12-11 |
| 08809302587248 | Soosung Elastic Bandage | soosung medical | 2025-12-11 |
| 10080196571925 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-10-20 |
| 10080196745647 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-08-14 |
| 10080196745630 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-08-14 |
| 10080196745593 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-08-14 |
| 10080196691159 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-08-14 |
| 10080196278237 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-08-14 |
| 10080196692378 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-05-29 |
| 10080196745623 | Medline | MEDLINE INDUSTRIES, INC. | 2024-02-28 |
| 10080196691098 | Medline | MEDLINE INDUSTRIES, INC. | 2024-02-28 |
| 10080196745609 | Medline | MEDLINE INDUSTRIES, INC. | 2024-02-28 |
| 10080196685035 | COLABEL | MEDLINE INDUSTRIES, INC. | 2023-10-13 |
| 10080196058860 | Medline | MEDLINE INDUSTRIES, INC. | 2023-10-05 |
| 10080196058884 | Medline | MEDLINE INDUSTRIES, INC. | 2023-10-05 |
| 10080196288069 | Medline | MEDLINE INDUSTRIES, INC. | 2022-06-11 |
| 10080196692491 | Medline | MEDLINE INDUSTRIES, INC. | 2021-02-23 |
| 10080196735495 | Medline | MEDLINE INDUSTRIES, INC. | 2021-02-22 |
| 10080196735501 | Medline | MEDLINE INDUSTRIES, INC. | 2021-02-02 |
| 10080196575978 | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. | 2021-01-21 |
| 10080196575817 | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. | 2021-01-21 |
| 10080196575909 | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. | 2021-01-20 |
| 10080196694068 | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. | 2021-01-19 |
| 10080196575732 | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. | 2021-01-19 |