Clarus Models 1230 and 1231 Laparo-Needle
FDA 510(k) K915725 · Clarus Medical Systems, Inc.
510(k) numberK915725
Submission
- Device name
- Clarus Models 1230 and 1231 Laparo-Needle
- Applicant
- Clarus Medical Systems, Inc.
Minneapolis, MN, US - Received
- December 20, 1991
- Decision date
- November 16, 1992
- 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 |
| K942484 | Verres NeedleFHO · Traditional | Linvatec Corp. | 06/24/1994SE |
| K930474 | Needle, Pneumoperitoneum, Spring LoadedFHO · Traditional | Ranfac, Corp. | 07/23/1993SE |
| K914426 | Entree NeedleFHO · Traditional | Core Dynamics, Inc. | 11/27/1991SE |
More from Core Dynamics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K980588 | Clarus Endoscopic Discectomy System Sitetrac Model 6000GAD · Traditional | 08/18/1998SE |
| K974579 | Percscope Model 2600HRX · Traditional | 02/18/1998SE |
| K971584 | Clarus Model 2127-900 Series Endoscope Adater (2127-900 Series)OCV · Traditional | 05/23/1997SE |
| K971455 | Clarus Model 5197 SightliteFTI · Traditional | 05/20/1997SE |
| K960915 | Clarus Neuropen Endoscopic Placement Kit Model 2125-XXXGWG · Traditional | 12/24/1996SE |
| K962255 | Clarus Murphypen ENDOSCOPE(2127-XXX)EOB · Traditional | 09/11/1996SE |
| K955598 | Clarus Spinepen Model 2126GWG · Traditional | 02/06/1996SE |
| K953685 | Instrument ScopeGWG · Traditional | 10/12/1995SE |
| K945633 | Neuro Channel Endoscope Model 2232GWG · Traditional | 09/19/1995SE |
| K945296 | Clarus Phoenix Neuro Endoscope Model 2160GWG · Traditional | 07/14/1995SE |
Questions and answers
When was Clarus Models 1230 and 1231 Laparo-Needle cleared by the FDA?
Clarus Models 1230 and 1231 Laparo-Needle (K915725) received a 510(k) decision of Substantially Equivalent on November 16, 1992, 332 days after the submission was received.
What is the product code of K915725?
The FDA product code is FHO – Pneumoperitoneum Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1500.