FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE
K Number: K860103
·
Decision Feb 12, 1986
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
12
Applicant Total
7
Review Days
33
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Basic Information
- Device Name
- MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE
- K Number
- K860103
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Endotherapeutics
- Date Received
- January 10, 1986
- Decision Date
- February 12, 1986
- Product Code
- GCP
- 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 |
|---|---|---|---|
| GCP | Endoscope, Ac-Powered And Accessories | FDA class 2 | Gastroenterology, Urology |
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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 |
| K852031 | ENDOPORT 5MM | Aug 13, 1985 | Substantially Equivalent |
| K844619 | ENDONEEDLE | Jan 9, 1985 | Substantially Equivalent |
| K841716 | ENDOPORT EROCAR | Jun 28, 1984 | Substantially Equivalent |