Access Expansion System
FDA 510(k) K951894 · Micro-Medical Devices, Inc.
510(k) numberK951894
Submission
- Device name
- Access Expansion System
- Applicant
- Micro-Medical Devices, Inc.
Castle Pines Village, CO, US - Received
- April 24, 1995
- Decision date
- June 15, 1995
- Decision
- Unknown (SESK)
- 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 |
| K943624 | Elmed Pneumoperitoneum NeedlesFHO · Traditional | Henke-Sass, Wolf GmbH | 08/10/1994SE |
| K942484 | Verres NeedleFHO · Traditional | Linvatec Corp. | 06/24/1994SE |
| 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 |
More from Core Dynamics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K003695 | Microscope-Stainless Steel/Fiber Optic: .5-2.6MM Model MMD 4500 Series and 2.7-5.0MM…HRX · Traditional | 02/14/2001SE |
| K983882 | Micro Endoscope-Stainless Steel, Model MMD-1300, Micro Endoscope-Polyimide,Model MMD-1400HXR · Traditional | 03/15/1999SE |
| K963675 | The Flat Panel Steirle Drape System(Tm), Video Monitor Sterile DrapeKKX · Traditional | 01/27/1997SE |
| K951482 | Endoscopes, Fiber Optic Laparoscopes, (Sterilizable)GCJ · Traditional | 09/14/1995SE |
| K945656 | The Coupler/Drape(Tm), Video Camera Sterile DrapeKKX · Traditional | 03/28/1995SE |
| K940141 | Laparaoscopes Electronic with Sterile SheathGCJ · Traditional | 05/19/1994SE |
| K936213 | Arthroscopes and AccessoriesHRX · Traditional | 05/18/1994SE |
Questions and answers
When was Access Expansion System cleared by the FDA?
Access Expansion System (K951894) received a 510(k) decision of Unknown on June 15, 1995, 52 days after the submission was received.
What is the product code of K951894?
The FDA product code is FHO – Pneumoperitoneum Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1500.