Panels › Gastroenterology, Urology › Product code FHO · Class 2
Pneumoperitoneum Needle
Regulation 876.1500
0510(k)s in 12 months (15 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FHO
| Company | 510(k)s | Recalls |
|---|---|---|
| Origin Medsystems, Inc. | 2 | 0 |
| Apple Medical Corp. | 1 | 0 |
| Clarus Medical Systems, Inc. | 1 | 0 |
| Core Dynamics, Inc. | 1 | 0 |
| Endotherapeutics | 1 | 0 |
| Gibbons Surgical Corp. | 1 | 0 |
| Henke-Sass, Wolf GmbH | 1 | 0 |
| Linvatec Corp. | 1 | 0 |
| Micro-Medical Devices, Inc. | 1 | 0 |
| Ranfac, Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 14, 2017 | K172120 | Veress Needle Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd, CN | FHO |
| Aug 2, 2013 | K121370 | VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE Vectec | FHO |
| Apr 10, 2001 | K010779 | MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT Gibbons Surgical Corp. | FHO |
| Mar 27, 1997 | K970788 | PNEUMO-MATIC INSUFFLATION NEEDLE Apple Medical Corp. | FHO |
| Aug 5, 1996 | K960574 | ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM Sherwood Medical Co. | FHO |
| Jun 15, 1995 | K951894 | ACCESS EXPANSION SYSTEM Micro-Medical Devices, Inc. | FHO |
| Aug 10, 1994 | K943624 | ELMED PNEUMOPERITONEUM NEEDLES Henke-Sass, Wolf GmbH, DE | FHO |
| Jun 24, 1994 | K942484 | VERRES NEEDLE Linvatec Corp. | FHO |
| Jul 23, 1993 | K930474 | NEEDLE, PNEUMOPERITONEUM, SPRING LOADED Ranfac, Corp. | FHO |
| Nov 16, 1992 | K915725 | CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE Clarus Medical Systems, Inc. | FHO |
| Nov 27, 1991 | K914426 | ENTREE NEEDLE Core Dynamics, Inc. | FHO |
| Nov 8, 1991 | K913816 | ORIGINEEDLE, MODIFICATION Origin Medsystems, Inc. | FHO |
| Mar 29, 1991 | K904849 | ORIGINEEDLE(TM) Origin Medsystems, Inc. | FHO |
| Oct 2, 1986 | K863330 | DISPOSABLE PNEUMOPERITONEUM NEEDLE United States Surgical, A Division of Tyco Healthc | FHO |
| Jan 9, 1985 | K844619 | ENDONEEDLE Endotherapeutics | FHO |
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