Binder, Abdominal
An abdominal binder is a supportive compression garment worn around the abdomen, used post-surgically or for conditions requiring abdominal support such as wound management or hernia care. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FSD, regulated under 21 CFR 880.5160, within the General Hospital medical specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- FSD
- Device Class
- FDA class 1
- Regulation Number
- 880.5160
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K892379 | THE POUCH GROIN & ABDOMINAL STRESS AID | Jul 20, 1989 | Substantially Equivalent | Kuhn Industries |
| K822817 | DOCE ALL-IN-THE-EAR AID | Jan 18, 1983 | Substantially Equivalent | Fidelty Hearing Instruments, Inc. |
| K810379 | EARETTE HEARING AID SEARS #8054 | Mar 04, 1981 | Substantially Equivalent | Oticon Corp. |
| K770162 | MATERNITY SUPPORTER | Feb 09, 1977 | Substantially Equivalent | R.G. Moore |
| K760772 | DISPOSABLE ABDOMINAL BINDER | Nov 03, 1976 | Substantially Equivalent | Tecnol New Jersey Wound Care, Inc. |
FEI Numbers
This FDA classification entry is associated with 106 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 106 registration numbers. Click on an entry to view related FDA registrations.