FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOPORT EROCAR
K Number: K841716
·
Decision Jun 28, 1984
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
8
Applicant Total
7
Review Days
64
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Basic Information
- Device Name
- ENDOPORT EROCAR
- K Number
- K841716
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5090
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Endotherapeutics
- Date Received
- April 25, 1984
- Decision Date
- June 28, 1984
- Product Code
- FBQ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| FBQ | Trocar, Gastro-Urology | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FBQ), ordered by most recent decision date.
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SABRE BT BLUNT0TIP SURGICAL TROCAR
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Other Clearances by Endotherapeutics
| K Number | Device Name | ||
|---|---|---|---|
| K870855 | UROSCAN | Jun 9, 1987 | Substantially Equivalent |
| K860192 | ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE | Mar 17, 1986 | Substantially Equivalent |
| K860102 | MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE | Feb 12, 1986 | Substantially Equivalent |
| K860103 | MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE | Feb 12, 1986 | Substantially Equivalent |
| K852031 | ENDOPORT 5MM | Aug 13, 1985 | Substantially Equivalent |
| K844619 | ENDONEEDLE | Jan 9, 1985 | Substantially Equivalent |