FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FOREIGN BODY PROTECTOR
K Number: K841258
·
Decision Jul 9, 1984
Classifications
1
FEI Numbers
116
Registration Numbers
116
Same Product Code
100
Applicant Total
9
Review Days
105
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Basic Information
- Device Name
- FOREIGN BODY PROTECTOR
- K Number
- K841258
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Jayco Pharmaceuticals
- Date Received
- March 26, 1984
- Decision Date
- July 9, 1984
- Product Code
- FED
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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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 |
| K842009 | ABDOMINAL PARACENTESIS TRAY | Oct 23, 1984 | Substantially Equivalent |
| K842001 | LIVER BIOPSY TRAY | Oct 15, 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 |