Product Code: FJZ
FDA class 2
21 CFR 876.5820
Declotting Tray, Kit (Including Contents)
Gastroenterology, Urology
The Declotting Tray (Including Contents) is a pre-assembled procedural kit used to restore patency to clotted shunt or catheter lines in dialysis patients. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FJZ, regulated under 21 CFR 876.5820 in the Gastroenterology and Urology specialty. This device is eligible for third-party review.
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
5
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Basic Information
- Product Code
- FJZ
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K821666 | STERILE SURGICAL DRAPES | Jun 21, 1982 | Substantially Equivalent | Phoenix Glove Co. |
| K821313 | SURGICAL UTILITY DRAPE | Jun 21, 1982 | Substantially Equivalent | Megaplast, Inc. |
| K760995 | DECOLLATING TRAY | Jan 06, 1977 | Substantially Equivalent | Dravon Medical, Inc. |