Needle, Pneumoperitoneum, Spring Loaded
FDA 510(k) K930474 · Ranfac, Corp.
510(k) numberK930474
Submission
- Device name
- Needle, Pneumoperitoneum, Spring Loaded
- Applicant
- Ranfac, Corp.
Avon, MA, US - Received
- January 28, 1993
- Decision date
- July 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K942484 | Verres NeedleFHO · Traditional | Linvatec Corp. | 06/24/1994SE |
| 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 |
More from Core Dynamics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K223612 | Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)KNW · Special | 02/21/2023SE |
| K202287 | Ran-Flex-B Bone Marrow Aspiration NeedleKNW · Traditional | 09/18/2020SE |
| K190177 | J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,KNW · Special | 06/12/2019SE |
| K183146 | Ranfac Cartilage Biopsy NeedleKNW · Traditional | 04/25/2019SE |
| K162932 | Ranfac Fat Aspiration CannulaMUU · Traditional | 01/19/2017SE |
| K150156 | Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration…MUU · Traditional | 10/19/2015SE |
| K150563 | Marrow Cellution Bone Marrow Aspiration NeedleKNW · Traditional | 05/22/2015SE |
| K140991 | Ranfac Aspiration Needle with Adjustable GuideKNW · Traditional | 09/11/2014SE |
| K131157 | Ranfac Bone Marrow Aspiration NeedleKNW · Traditional | 10/22/2013SE |
| K031344 | Ranfac Goldenberg Snarecoil Soft Tissue Biopsy (GSS) NeedleKNW · Traditional | 05/23/2003SE |
Questions and answers
When was Needle, Pneumoperitoneum, Spring Loaded cleared by the FDA?
Needle, Pneumoperitoneum, Spring Loaded (K930474) received a 510(k) decision of Substantially Equivalent on July 23, 1993, 176 days after the submission was received.
What is the product code of K930474?
The FDA product code is FHO – Pneumoperitoneum Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1500.