FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ABDOMINAL PARACENTESIS TRAY
K Number: K842009
·
Decision Oct 23, 1984
Classifications
1
FEI Numbers
875
Registration Numbers
875
Same Product Code
75
Applicant Total
9
Review Days
159
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Basic Information
- Device Name
- ABDOMINAL PARACENTESIS TRAY
- K Number
- K842009
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Jayco Pharmaceuticals
- Date Received
- May 17, 1984
- Decision Date
- October 23, 1984
- Product Code
- FSM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FSM | Tray, Surgical, Instrument | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FSM), ordered by most recent decision date.
INSTRUMENT TRAY LINER
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SINGLE USE INSTRUMENT TRAY
FDA 510(k)
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SURGICAL INSTRUMENT TRAY
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ARTHROSCOPY TRAY
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OPEN HEART TRAY
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HEART CATH TRAY
FDA 510(k)
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·General, Plastic Surgery
Other Clearances by Jayco Pharmaceuticals
| K Number | Device Name | ||
|---|---|---|---|
| K844690 | ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT | Jan 2, 1985 | Substantially Equivalent |
| K844689 | ENDOSCOPIC MANUAL AIR INSUFFLATOR | Jan 2, 1985 | Substantially Equivalent |
| K844691 | ENDOSCOPIC ASPIRATION CATHETER SET | Jan 2, 1985 | Substantially Equivalent |
| K842001 | LIVER BIOPSY TRAY | Oct 15, 1984 | Substantially Equivalent |
| K841258 | FOREIGN BODY PROTECTOR | Jul 9, 1984 | Substantially Equivalent |
| K840800 | POLYP-SAVER SLEVE | Mar 23, 1984 | Substantially Equivalent |
| K830781 | ENDO-GUARD | Mar 31, 1983 | Substantially Equivalent |
| K810875 | FECAL STAINING KIT | May 1, 1981 | Substantially Equivalent |