Coagulator, Culdoscopic (And Accessories)
The Culdoscopic Coagulator (and accessories) is a surgical device used during culdoscopic procedures to deliver electrosurgical coagulation energy to pelvic structures visualized through a posterior vaginal wall approach, such as for tubal sterilization. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HFI, regulated under 21 CFR 884.4160, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- HFI
- Device Class
- FDA class 2
- Regulation Number
- 884.4160
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K151567 | ENDOPLUS hand-held laparoscopic instruments | Dec 23, 2015 | Substantially Equivalent | Endoplus |
| K925960 | FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Jun 07, 1994 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K925957 | SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Jun 07, 1994 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K936026 | COOK LAPAROSCOPIC MINI RETRACTOR SET | Mar 11, 1994 | Substantially Equivalent | Cook Urological, Inc. |
| K925114 | LAPAROSCOPIC INSTRUMENTS | Feb 28, 1994 | Substantially Equivalent | Endo Technic Corp. |
| K924148 | DIAMOND-SHARP(R) TROCARS | Feb 28, 1994 | Substantially Equivalent | Snowden-Pencer |
| K930571 | REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING | Feb 01, 1994 | Substantially Equivalent | Numed Technologies, Inc. |
| K844053 | CANON 60 DEGREE FUNDUS CAMERA CF-60S | Dec 19, 1984 | Substantially Equivalent | Canon USA, Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.