Scissors for Laparoscopic Surgery OB/GYN Use
FDA 510(k) K925957 · Zinnanti Surgical Instruments, Inc.
510(k) numberK925957
Submission
- Device name
- Scissors for Laparoscopic Surgery OB/GYN Use
- Applicant
- Zinnanti Surgical Instruments, Inc.
Chatsworth, CA, US - Received
- November 24, 1992
- Decision date
- June 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K936026 | Cook Laparoscopic Mini Retractor SetHFI · Traditional | Cook Urological, Inc. | 03/11/1994SE |
| K925114 | Laparoscopic InstrumentsHFI · Traditional | Endo Technic Corp. | 02/28/1994SE |
| 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 |
More from Canon USA, Inc.
| 510(k) | Device | Decision |
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| K925501 | Nylon Coated SpeculaHIB · Traditional | 06/13/1997SE |
| K941458 | Uterine Manipulator/Injector with SpringLKF · Traditional | 01/25/1995SE |
| K941457 | Uterine Injector with SpringLKF · Traditional | 01/24/1995SE |
| K925560 | Zsi Loop, Zsi Ball & Zsi Needle ElectrodesHGI · Traditional | 08/30/1994SE |
| K925960 | Forceps for Laparoscopic Surgery OB/GYN UseHFI · Traditional | 06/07/1994SE |
| K926021 | Needle Holders & Access for Lapar Surg-Ob/Gyn UseHET · Traditional | 04/07/1994SE |
| K925958 | Scissor for Laparoscopic Surgery Gu UseGCJ · Traditional | 03/24/1994SE |
| K926181 | Zsi Laparoscopes-General & Plastic SurgeryGCJ · Traditional | 12/17/1993SE |
| K926016 | Needle Holders & Access for Lapar Surg-Gu UseGCJ · Traditional | 11/12/1993SE |
| K925959 | Forceps for Laparoscopic Surgery Gu UseGCJ · Traditional | 11/12/1993SE |
Questions and answers
When was Scissors for Laparoscopic Surgery OB/GYN Use cleared by the FDA?
Scissors for Laparoscopic Surgery OB/GYN Use (K925957) received a 510(k) decision of Substantially Equivalent on June 7, 1994, 560 days after the submission was received.
What is the product code of K925957?
The FDA product code is HFI – Coagulator, Culdoscopic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4160.