Product code FHO
- Device name
- Pneumoperitoneum Needle
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- For establishment of a pneumoperitoneum in abdomen.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172120 | Veress Needle | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017-09-14 |
| K121370 | VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE | Vectec | 2013-08-02 |
| K010779 | MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT | Gibbons Surgical Corp. | 2001-04-10 |
| K970788 | PNEUMO-MATIC INSUFFLATION NEEDLE | Apple Medical Corp. | 1997-03-27 |
| K960574 | ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM | Sherwood Medical Co. | 1996-08-05 |
| K951894 | ACCESS EXPANSION SYSTEM | Micro-Medical Devices, Inc. | 1995-06-15 |
| K943624 | ELMED PNEUMOPERITONEUM NEEDLES | Henke-Sass, Wolf GmbH | 1994-08-10 |
| K942484 | VERRES NEEDLE | Linvatec Corp. | 1994-06-24 |
| K930474 | NEEDLE, PNEUMOPERITONEUM, SPRING LOADED | Ranfac, Corp. | 1993-07-23 |
| K915725 | CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE | Clarus Medical Systems, Inc. | 1992-11-16 |
| K914426 | ENTREE NEEDLE | Core Dynamics, Inc. | 1991-11-27 |
| K913816 | ORIGINEEDLE, MODIFICATION | Origin Medsystems, Inc. | 1991-11-08 |
| K904849 | ORIGINEEDLE(TM) | Origin Medsystems, Inc. | 1991-03-29 |
| K863330 | DISPOSABLE PNEUMOPERITONEUM NEEDLE | United States Surgical, A Division of Tyco Healthc | 1986-10-02 |
| K844619 | ENDONEEDLE | Endotherapeutics | 1985-01-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06937845500607 | GTK | Guangzhou T.K Medical Instrument Co.,Ltd. | 2024-05-23 |
| 06937845500614 | GTK | Guangzhou T.K Medical Instrument Co.,Ltd. | 2024-05-23 |
| 00810143450750 | MD EndoGuidance Laparoscopic Insufflator | Medical Disposables Corp | 2023-07-31 |
| 00810143450545 | MD EndoGuidance Laparoscopic Insufflator | Medical Disposables Corp | 2023-07-31 |
| 00858690006990 | INSUFFLATION NEEDLE,15CM | RANFAC CORP. | 2018-03-02 |
| 04714127862026 | Veress Needle | UNIMAX MEDICAL SYSTEMS INC. | 2017-06-19 |
| 00858690006204 | INSUFFLATION NEEDLE,12CM | RANFAC CORP. | 2017-05-08 |
| 04714127862002 | Veress Needle | UNIMAX MEDICAL SYSTEMS INC. | 2017-01-09 |
| 06955797740018 | Unimicro | Unimicro Medical Systems (ShenZhen) Co., Ltd. | 2016-12-22 |
| 06955797740025 | Unimicro | Unimicro Medical Systems (ShenZhen) Co., Ltd. | 2016-12-22 |
| 20884521080819 | Surgineedle | Covidien LP | 2016-10-20 |
| 00749756261340 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-24 |
| 00749756261333 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-24 |
| 00749756036191 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-24 |
| 00749756030519 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-24 |
| 30653405011914 | EXCEL | Conmed Corporation | 2016-09-24 |
| 30653405011907 | EXCEL | Conmed Corporation | 2016-09-24 |
| 20653405077920 | CORE DYNAMICS | Conmed Corporation | 2016-09-24 |
| 20653405046049 | CORE DYNAMICS | Conmed Corporation | 2016-09-24 |
| 20653405046032 | CORE DYNAMICS | Conmed Corporation | 2016-09-24 |
| 10884521080805 | Surgineedle | Covidien LP | 2016-09-24 |
| 00812608021048 | PMI | PROGRESSIVE MEDICAL, INC. | 2016-09-23 |
| 20885403067942 | V. Mueller | CAREFUSION 2200, INC | 2016-09-21 |
| 20885403067935 | V. Mueller | CAREFUSION 2200, INC | 2016-09-21 |
| 10885403067945 | V. Mueller | STERIS CORPORATION | 2016-09-21 |
| 10885403067938 | V. Mueller | STERIS CORPORATION | 2016-09-21 |
| 03700393300646 | NA | PETERS SURGICAL | 2016-09-12 |
| 03700393300622 | NA | PETERS SURGICAL | 2016-09-12 |
| 00888937003673 | Pneumo-Matic | Coopersurgical, Inc. | 2016-06-07 |
| 00888937003666 | Pneumo-Matic | Coopersurgical, Inc. | 2016-06-07 |