FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
IRRIGATION TRAY
K Number: K896800
·
Decision May 24, 1990
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
40
Applicant Total
28
Review Days
174
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- IRRIGATION TRAY
- K Number
- K896800
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6960
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Applicant
- Westmark, Sterile Packing Systems, Inc. (Sps)
- Date Received
- December 1, 1989
- Decision Date
- May 24, 1990
- Product Code
- KYZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KYZ | Syringe, Irrigating (Non Dental) | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KYZ), ordered by most recent decision date.
OtoSet- Ear Cleaning System
FDA 510(k)
FDA Class 1
·General Hospital
SINGLE CANNULA EXTENDED APPLICATOR
FDA 510(k)
FDA Class 1
·General Hospital
TISSU TRANS HARVEST TUBING
FDA 510(k)
FDA Class 1
·General Hospital
TISSU-TRANS
FDA 510(k)
FDA Class 1
·General Hospital
QS DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
IRRIGATION SYRINGE KIT
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Westmark, Sterile Packing Systems, Inc. (Sps)
| K Number | Device Name | ||
|---|---|---|---|
| K896799 | PARACERVICAL/PUDENDAL TRAYS | Apr 23, 1990 | Substantially Equivalent |
| K896559 | INFANT FEEDING TUBE | Mar 13, 1990 | Substantially Equivalent |
| K896794 | SPECIMEN CONTAINER | Mar 1, 1990 | Substantially Equivalent |
| K896806 | CATHETER PLUG/PROTECTOR | Feb 26, 1990 | Substantially Equivalent |
| K896798 | TRACHEOSTOMY TRAY | Feb 22, 1990 | Substantially Equivalent |
| K896797 | SUCTION CATHETER KIT | Feb 16, 1990 | Substantially Equivalent |
| K896215 | MERCY HIP/KNEE PACK | Feb 13, 1990 | Substantially Equivalent |
| K896804 | MANIFOLD | Feb 8, 1990 | Substantially Equivalent |
| K896556 | UNIVERSAL POOLE SUCTION TUBE | Feb 6, 1990 | Substantially Equivalent |
| K896562 | STOPCOCK | Feb 6, 1990 | Substantially Equivalent |