Cutter Cast 7
FDA 510(k) K770742 · Cutter Laboratories, Inc.
510(k) numberK770742
Submission
- Device name
- Cutter Cast 7
- Applicant
- Cutter Laboratories, Inc.
Mchenry, IL, US - Received
- April 22, 1977
- Decision date
- April 28, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ITG – Bandage, Cast
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3025
- Specialty
- Physical Medicine
Other 510(k)s with product code ITG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K873111 | Conforma(Tm) Plaster BandagesITG · Traditional | The Kendal Co. | 10/09/1987SE |
| K862115 | Dekna Band KitITG · Traditional | Deknatel, Inc. | 08/19/1986SE |
| K842573 | T.P.G. Cast TapeITG · Traditional | The Poly Group, Inc. | 08/10/1984SE |
| K840416 | HexceliteITG · Traditional | Hexcel Medical | 03/23/1984SE |
| K833732 | Non Wetting Undercast PaddingITG · Traditional | American Medical Disposable, Inc. | 12/12/1983SE |
| K832992 | Soffban Orthopedic PaddingITG · Traditional | Smith & Nephew, Inc. | 11/14/1983SE |
| K832237 | Orthopedic Casting Tape MaxcastITG · Traditional | Cutter Laboratories, Inc. | 08/16/1983SE |
| K830650 | Support Products Example Proset CastITG · Traditional | Isopedix Corp. | 07/07/1983SE |
| K831492 | Yesona Plaster of Paris BandageITG · Traditional | Watson Phillips Y Cia. Sucs., S.A. DE C.V. | 06/30/1983SE |
| K820890 | Urethane Orthopaedic Casting TapeITG · Traditional | Hexcel Medical | 06/23/1982SE |
More from Hexcel Medical
| 510(k) | Device | Decision |
|---|---|---|
| K861315 | Hyperbaric Penetration Extension SetCBF · Traditional | 05/21/1986SE |
| K854106 | BaysilexELW · Traditional | 03/17/1986SE |
| K842324 | PerfourmELW · Traditional | 11/09/1984SE |
| K834106 | Intravenous Infusion ControllerLDR · Traditional | 05/30/1984SE |
| K832237 | Orthopedic Casting Tape MaxcastITG · Traditional | 08/16/1983SE |
| K823214 | Dosimetric Release Program - Admin. SetFPA · Traditional | 01/12/1983SE |
| K821326 | Cutter Bond Polycarboxylate CementEMA · Traditional | 05/28/1982SE |
| K813532 | Cutterbond Zinc Phosphate CementEMA · Traditional | 03/02/1982SE |
| K802105 | C-BladeHWE · Traditional | 09/16/1980SE |
| K802104 | C-SplintIQI · Traditional | 09/16/1980SE |
Questions and answers
When was Cutter Cast 7 cleared by the FDA?
Cutter Cast 7 (K770742) received a 510(k) decision of Substantially Equivalent on April 28, 1977, 6 days after the submission was received.
What is the product code of K770742?
The FDA product code is ITG – Bandage, Cast, a Class I (low risk) device regulated under 21 CFR 890.3025.