Tray, Surgical, Needle
A surgical needle tray is a container used in the operating room to organize and store needles during surgical procedures, supporting safe handling and sterile technique. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FSH, regulated under 21 CFR 878.4800, within the General, Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- FSH
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- 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 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K884876 | S 4 INSTRUMENT STAND | Dec 15, 1988 | Substantially Equivalent | Carl Zeiss, Inc. |
| K883578 | S 21 INSTRUMENT STAND | Sep 13, 1988 | Substantially Equivalent | Carl Zeiss, Inc. |
| K821921 | STAND, SURG. INSTRUMENT & DRESSING | Jul 30, 1982 | Substantially Equivalent | Emerson-Sack-Warner Corp. |
| K813338 | BIOPSY NEEDLES & TRAYS | Jan 28, 1982 | Substantially Equivalent | American Pharmaseal Div. Ahsc |
| K813337 | SKINNY CHIBA NEEDLE & TRAY | Jan 28, 1982 | Substantially Equivalent | American Pharmaseal Div. Ahsc |
| K813335 | PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY | Jan 08, 1982 | Substantially Equivalent | American Pharmaseal Div. Ahsc |
| K780759 | MODEL 902 STAND | May 19, 1978 | Substantially Equivalent | Applied Medical Research |
| K772188 | FSH RIA KIT (125I) | Dec 22, 1977 | Substantially Equivalent | Diagnostic Products Corp. |
FEI Numbers
This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.