FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE
K Number: K860102
·
Decision Feb 12, 1986
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
7
Review Days
33
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE
- K Number
- K860102
- 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
- FHP
- 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 |
|---|---|---|---|
| FHP | Needle, Pneumoperitoneum, Simple | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FHP), ordered by most recent decision date.
View allOther 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 |
| 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 |
| K841716 | ENDOPORT EROCAR | Jun 28, 1984 | Substantially Equivalent |