Verres Needle
FDA 510(k) K942484 · Linvatec Corp.
510(k) numberK942484
Submission
- Device name
- Verres Needle
- Applicant
- Linvatec Corp.
Largo, FL, US - Received
- May 25, 1994
- Decision date
- June 24, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FHO – Pneumoperitoneum Needle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
For establishment of a pneumoperitoneum in abdomen.
Other 510(k)s with product code FHO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172120 | Veress NeedleFHO · Traditional | Wickimed (Huizhou) Medical Equipment… | 09/14/2017SE |
| K121370 | Vectec Disposable Pneumoperitoneum NeedleFHO · Traditional | Vectec | 08/02/2013SE |
| K010779 | Modification To:Laparoscopic/Endoscopic InstrumentFHO · Special | Gibbons Surgical Corp. | 04/10/2001SE |
| K970788 | Pneumo-Matic Insufflation NeedleFHO · Traditional | Apple Medical Corp. | 03/27/1997SE |
| K960574 | Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray and Thoracic Catheter…FHO · Traditional | Sherwood Medical Co. | 08/05/1996SE |
| K951894 | Access Expansion SystemFHO · Traditional | Micro-Medical Devices, Inc. | 06/15/1995SESK |
| K943624 | Elmed Pneumoperitoneum NeedlesFHO · Traditional | Henke-Sass, Wolf GmbH | 08/10/1994SE |
| K930474 | Needle, Pneumoperitoneum, Spring LoadedFHO · Traditional | Ranfac, Corp. | 07/23/1993SE |
| K915725 | Clarus Models 1230 and 1231 Laparo-NeedleFHO · Traditional | Clarus Medical Systems, Inc. | 11/16/1992SE |
| K914426 | Entree NeedleFHO · Traditional | Core Dynamics, Inc. | 11/27/1991SE |
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Questions and answers
When was Verres Needle cleared by the FDA?
Verres Needle (K942484) received a 510(k) decision of Substantially Equivalent on June 24, 1994, 30 days after the submission was received.
What is the product code of K942484?
The FDA product code is FHO – Pneumoperitoneum Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1500.