FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LAPAROSCOPIC INSTRUMENTS
K Number: K925114
·
Decision Feb 28, 1994
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
7
Applicant Total
10
Review Days
507
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
- LAPAROSCOPIC INSTRUMENTS
- K Number
- K925114
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endo Technic Corp.
- Date Received
- October 9, 1992
- Decision Date
- February 28, 1994
- Product Code
- HFI
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HFI | Coagulator, Culdoscopic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HFI), ordered by most recent decision date.
ENDOPLUS hand-held laparoscopic instruments
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COOK LAPAROSCOPIC MINI RETRACTOR SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DIAMOND-SHARP(R) TROCARS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Endo Technic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K990908 | MILLENNIUM | May 27, 1999 | Substantially Equivalent |
| K971459 | DERMALASE | Jul 18, 1997 | Substantially Equivalent |
| K925079 | LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) | Aug 24, 1994 | Substantially Equivalent |
| K930756 | LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE | Mar 9, 1994 | Substantially Equivalent |
| K924058 | TROCAR | Mar 30, 1993 | Substantially Equivalent |
| K914825 | 1-125 ENDOSEED | Mar 19, 1992 | Substantially Equivalent |
| K910200 | LASER-35 | May 9, 1991 | Substantially Equivalent |
| K864976 | SOLUSET CALCIUM DEMINERALIZING SOLUTION | Feb 27, 1987 | Substantially Equivalent |
| K862129 | SET CANAL SEALER PASTE | Jul 22, 1986 | Substantially Equivalent |