Pneumo-Matic Insufflation Needle
FDA 510(k) K970788 · Apple Medical Corp.
510(k) numberK970788
Submission
- Device name
- Pneumo-Matic Insufflation Needle
- Applicant
- Apple Medical Corp.
Bolton, MA, US - Received
- March 4, 1997
- Decision date
- March 27, 1997
- 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 |
| 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 |
| 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 |
|---|---|---|
| K061651 | Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158HGI · Traditional | 10/20/2006SE |
| K050256 | Apple Medical/Ob Mobius Elastic RetractorGAD · Traditional | 04/26/2005SE |
| K041131 | Apple Medical Ob Mobius Elastic RetractorGCJ · Traditional | 05/13/2004SE |
| K014005 | Apple Medical Mobius Elastic RetractorGCJ · Traditional | 02/15/2002SE |
| K000026 | Apple Medical One-Touch Uterine SamplerHHK · Traditional | 03/31/2000SE |
| K961460 | Lweet Cone Biopsy InstrumentHGI · Traditional | 11/19/1996SE |
| K952841 | The AssistantFHA · Traditional | 08/18/1995SE |
| K941506 | Ureteral IlluminatorFCS · Traditional | 10/05/1994SE |
Questions and answers
When was Pneumo-Matic Insufflation Needle cleared by the FDA?
Pneumo-Matic Insufflation Needle (K970788) received a 510(k) decision of Substantially Equivalent on March 27, 1997, 23 days after the submission was received.
What is the product code of K970788?
The FDA product code is FHO – Pneumoperitoneum Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1500.