FHO — Pneumoperitoneum Needle Class II
FDA product code FHO covers "Pneumoperitoneum Needle", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FHO
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
For establishment of a pneumoperitoneum in abdomen.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K172120 | wickimed (huizhou) medical equipment manufacturing co | Veress Needle | September 14, 2017 |
| K121370 | vectec | VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE | August 2, 2013 |
| K010779 | gibbons surgical | MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT | April 10, 2001 |
| K970788 | apple medical | PNEUMO-MATIC INSUFFLATION NEEDLE | March 27, 1997 |
| K960574 | sherwood medical | ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC C | August 5, 1996 |
| K951894 | micro-medical devices | ACCESS EXPANSION SYSTEM | June 15, 1995 |
| K943624 | henke-sass, wolf | ELMED PNEUMOPERITONEUM NEEDLES | August 10, 1994 |
| K942484 | linvatec | VERRES NEEDLE | June 24, 1994 |
| K930474 | ranfac | NEEDLE, PNEUMOPERITONEUM, SPRING LOADED | July 23, 1993 |
| K915725 | clarus medical systems | CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE | November 16, 1992 |
| K914426 | core dynamics | ENTREE NEEDLE | November 27, 1991 |
| K913816 | origin medsystems | ORIGINEEDLE, MODIFICATION | November 8, 1991 |
| K904849 | origin medsystems | ORIGINEEDLE(TM) | March 29, 1991 |
| K863330 | united states surgical, a division of tyco healthc | DISPOSABLE PNEUMOPERITONEUM NEEDLE | October 2, 1986 |
| K844619 | endotherapeutics | ENDONEEDLE | January 9, 1985 |