Product code ITG
- Device name
- Bandage, Cast
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3025
- Review panel
- PM
- 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 |
|---|---|---|---|
| K873111 | CONFORMA(TM) PLASTER BANDAGES | The Kendal Co. | 1987-10-09 |
| K862115 | DEKNA BAND KIT | Deknatel, Inc. | 1986-08-19 |
| K842573 | T.P.G. CAST TAPE | The Poly Group, Inc. | 1984-08-10 |
| K840416 | HEXCELITE | Hexcel Medical | 1984-03-23 |
| K833732 | NON WETTING UNDERCAST PADDING | American Medical Disposable, Inc. | 1983-12-12 |
| K832992 | SOFFBAN ORTHOPEDIC PADDING | Smith & Nephew, Inc. | 1983-11-14 |
| K832237 | ORTHOPEDIC CASTING TAPE MAXCAST | Cutter Laboratories, Inc. | 1983-08-16 |
| K830650 | SUPPORT PRODUCTS EXAMPLE PROSET CAST | Isopedix Corp. | 1983-07-07 |
| K831492 | YESONA PLASTER OF PARIS BANDAGE | Watson Phillips Y Cia. Sucs., S.A. DE C.V. | 1983-06-30 |
| K820890 | URETHANE ORTHOPAEDIC CASTING TAPE | Hexcel Medical | 1982-06-23 |
| K820155 | SPECIALIST CAST PADDING | Stan-Pak Ent. | 1982-02-12 |
| K820140 | WEBRIL CAST PADDING | Stan-Pak Ent. | 1982-02-12 |
| K813052 | ULTRACAST WATERLESS SYNTHETIC RESIN CAST | Zimmer, Inc. | 1982-02-04 |
| K813219 | CARAFLEX ELASTIC POLYMER PLASTER BANDA | Carapace, Inc. | 1981-12-17 |
| K811754 | CRYSTONA | Smith & Nephew, Inc. | 1981-07-20 |
| K811164 | URETHANE ORTHOPAEDIC CASTING TAPE | Hexcel Medical | 1981-05-27 |
| K810877 | ORTHOSIS BANDAGES | Ortho-Cast, Inc. | 1981-04-17 |
| K810111 | CELLONA PLASTER VARNISH | Secol Co. | 1981-02-04 |
| K802792 | CELLONA | Secol Co. | 1980-12-10 |
| K802796 | CELLAMIN | Secol Co. | 1980-11-24 |
| K800749 | IPOCON 7 | Ipos Luneburg | 1980-07-28 |
| K800695 | BVN | Donald J. Mangus, M.D. | 1980-05-02 |
| K800752 | PRE-PADDED PLASTER/PARIS BAND/SPLINTS | Ortho-Care, Inc. | 1980-04-21 |
| K800195 | COTTON UNDER CAST PADDING | Winn Hirsch & Assoc. | 1980-02-11 |
| K791831 | PROCAST | Medical Specialties, Inc. | 1979-09-24 |
| K791305 | FELTLOC CAST PADDING | Howmedica Corp. | 1979-07-30 |
| K791094 | 3M ORTHOPEDIC CASTING TAPE | 3M Company | 1979-07-24 |
| K790320 | DELTA-LITE | Johnson & Johnson Professionals, Inc. | 1979-05-18 |
| K771452 | CONFORM STRETCH BANDAGE (5SIZES) | Kendall Research Center | 1977-09-12 |
| K770929 | BANDAGES, SPEC. X-TRA HARD OR PLASTER | Johnson & Johnson Professionals, Inc. | 1977-06-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08711428052954 | 3M™ Scotchcast™ | Solventum US LLC | 2026-04-18 |
| 08711428052992 | 3M™ Scotchcast™ | Solventum US LLC | 2026-04-18 |
| 08711428053036 | 3M™ Scotchcast™ | Solventum US LLC | 2026-04-18 |
| 08711428053050 | 3M™ Scotchcast™ | Solventum US LLC | 2026-04-18 |
| 08711428052930 | 3M™ Scotchcast™ | Solventum US LLC | 2026-04-18 |
| 10080196284191 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-01-22 |
| 10080196832330 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-01-22 |
| 10192253045925 | Webril | Cardinal Health 200, LLC | 2025-09-23 |
| 10192253045888 | Webril | Cardinal Health 200, LLC | 2025-09-23 |
| 10192253045871 | Webril | Cardinal Health 200, LLC | 2025-09-23 |
| 10192253045864 | Webril | Cardinal Health 200, LLC | 2025-09-23 |
| 10197106823019 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-12-04 |
| 10080196745661 | Medline | MEDLINE INDUSTRIES, INC. | 2023-10-13 |
| 10080196745616 | Medline | MEDLINE INDUSTRIES, INC. | 2023-10-13 |
| 10080196824779 | Medline | MEDLINE INDUSTRIES, INC. | 2023-10-12 |
| 10080196284184 | Medline | MEDLINE INDUSTRIES, INC. | 2023-10-12 |
| 10197106447994 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-10-12 |
| 10195594653422 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-05-31 |
| 10612479194479 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2021-07-26 |
| 10612479194486 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2021-07-26 |
| 10612479194493 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2021-07-26 |
| 10612479194509 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2021-07-26 |
| 10612479194516 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2021-07-26 |
| 10612479194523 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2021-07-26 |
| 10612479194530 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2021-07-26 |
| 10612479194547 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2021-07-26 |
| 10612479192567 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-07-15 |
| 10612479192598 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-07-15 |
| 10612479192628 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-07-15 |
| 10612479192659 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-07-15 |