Laparoscopic Instruments
FDA 510(k) K925114 · Endo Technic Corp.
510(k) numberK925114
Submission
- Device name
- Laparoscopic Instruments
- Applicant
- Endo Technic Corp.
Northbrook, IL, US - Received
- October 9, 1992
- Decision date
- February 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HFI – Coagulator, Culdoscopic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4160
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HFI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K151567 | ENDOPLUS hand-held laparoscopic instrumentsHFI · Traditional | Endoplus | 12/23/2015SE |
| K925960 | Forceps for Laparoscopic Surgery OB/GYN UseHFI · Traditional | Zinnanti Surgical Instruments, Inc. | 06/07/1994SE |
| K925957 | Scissors for Laparoscopic Surgery OB/GYN UseHFI · Traditional | Zinnanti Surgical Instruments, Inc. | 06/07/1994SE |
| K936026 | Cook Laparoscopic Mini Retractor SetHFI · Traditional | Cook Urological, Inc. | 03/11/1994SE |
| K924148 | Diamond-Sharp(R) TrocarsHFI · Traditional | Snowden-Pencer | 02/28/1994SE |
| K930571 | Reusable Handle for Laparoscopic Inst. W/RotatingHFI · Traditional | Numed Technologies, Inc. | 02/01/1994SE |
| K844053 | Canon 60 Degree Fundus Camera CF-60SHFI · Traditional | Canon USA, Inc. | 12/19/1984SE |
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| K990908 | MillenniumMXF · Traditional | 05/27/1999SE |
| K971459 | DermalaseGEX · Traditional | 07/18/1997SE |
| K925079 | Laparoscopic Inst. (Scissors,Forceps,Needleholder)HET · Traditional | 08/24/1994SE |
| K930756 | Laparoscopic Irrigation/Aspiration HandpieceHET · Traditional | 03/09/1994SE |
| K924058 | TrocarGCJ · Traditional | 03/30/1993SE |
| K914825 | 1-125 EndoseedKXK · Traditional | 03/19/1992SE |
| K910200 | LASER-35GEX · Traditional | 05/09/1991SE |
| K864976 | Soluset Calcium Demineralizing SolutionEKS · Traditional | 02/27/1987SE |
| K862129 | Set Canal Sealer PasteEKM · Traditional | 07/22/1986SE |
Questions and answers
When was Laparoscopic Instruments cleared by the FDA?
Laparoscopic Instruments (K925114) received a 510(k) decision of Substantially Equivalent on February 28, 1994, 507 days after the submission was received.
What is the product code of K925114?
The FDA product code is HFI – Coagulator, Culdoscopic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4160.