FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT
K Number: K844690
·
Decision Jan 2, 1985
Classifications
1
FEI Numbers
188
Registration Numbers
188
Same Product Code
38
Applicant Total
9
Review Days
30
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Basic Information
- Device Name
- ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT
- K Number
- K844690
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Jayco Pharmaceuticals
- Date Received
- December 3, 1984
- Decision Date
- January 2, 1985
- Product Code
- FCL
- 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 |
|---|---|---|---|
| FCL | Forceps, Biopsy, Non-Electric | FDA class 1 | Gastroenterology, Urology |
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Other Clearances by Jayco Pharmaceuticals
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |