Board, Arm (With Cover), Sterile
The Board, Arm (With Cover), Sterile is a sterile padded board used to support and position a patient's arm at an appropriate angle during surgery, particularly for intravenous access or arm-related procedures. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BTX, regulated under 21 CFR 878.3910 in the General and Plastic Surgery specialty.
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Basic Information
- Product Code
- BTX
- Device Class
- FDA class 1
- Regulation Number
- 878.3910
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K935098 | BABY BOARD | Feb 15, 1994 | Substantially Equivalent | Sentry Medical Products, Inc. |
| K900175 | 4/1 ARMBOARD | Jan 24, 1990 | Substantially Equivalent | Infection Control Products, Inc. |
| K884838 | ALLEN PRONE ARMBOARD | Dec 15, 1988 | Substantially Equivalent | Edgewater Medical Systems, Inc. |
| K882524 | UNIVERSALLY ADJUSTABLE ARMBOARD | Jul 08, 1988 | Substantially Equivalent | Karlin Technology, Inc. |
| K881292 | ALLEN LATERAL ARMBOARD | Apr 07, 1988 | Substantially Equivalent | Edgewater Medical Systems, Inc. |
| K864670 | BOARD, ARM (WITH COVER) | Jan 12, 1987 | Substantially Equivalent | Anago, Inc. |
| K833664 | ARMBOARD AND THE BOARD | Dec 27, 1983 | Substantially Equivalent | Rick Robbin & Frederick Auerbach |
| K830018 | SAFE-T ARM BOARD | Jan 26, 1983 | Substantially Equivalent | Harvey A. Turner, M.D. |
| K823412 | ARM BOARD W/I.V COVERING | Dec 15, 1982 | Substantially Equivalent | Sage Products, Inc. |
| K811419 | SPRIO-LOOP | Jun 12, 1981 | Substantially Equivalent | Datamed, Inc. |
| K792147 | ARM SHIELD FOR ANESTHESIA | Dec 06, 1979 | Substantially Equivalent | Medical Innovations Corp. |
| K781233 | IV ARMBOARDS | Aug 14, 1978 | Substantially Equivalent | Fibre Formations, Inc. |
| K770391 | COVER, ARMBOARD, DISPOSABLE | Mar 07, 1977 | Substantially Equivalent | Precept, Inc. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.