ENDOPLUS hand-held laparoscopic instruments
FDA 510(k) K151567 · Endoplus
510(k) numberK151567
Submission
- Device name
- ENDOPLUS hand-held laparoscopic instruments
- Applicant
- Endoplus
Mundelein, IL, US - Received
- June 10, 2015
- Decision date
- December 23, 2015
- 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 |
|---|---|---|---|
| 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 |
| 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 |
Questions and answers
When was ENDOPLUS hand-held laparoscopic instruments cleared by the FDA?
ENDOPLUS hand-held laparoscopic instruments (K151567) received a 510(k) decision of Substantially Equivalent on December 23, 2015, 196 days after the submission was received.
What is the product code of K151567?
The FDA product code is HFI – Coagulator, Culdoscopic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4160.