Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent Surgical Instrument
FDA 510(k) K091215 · Power Medical Interventions, Inc.
510(k) numberK091215
Submission
- Device name
- Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent Surgical Instrument
- Applicant
- Power Medical Interventions, Inc.
Langhorne, PA, US - Received
- April 27, 2009
- Decision date
- May 18, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GDW – Staple, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4750
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GDW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260196 | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON…GDW · Traditional | Ethicon Endo-Surgery, LLC | 05/11/2026SE |
| K253657 | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray…GDW · Traditional | Covidien (Part of Medtronic) | 04/10/2026SE |
| K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 12/17/2025SE |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 05/14/2025SE |
| K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 02/25/2025SE |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 10/28/2024SE |
| K242679 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm…GDW · Special | Fengh Medical Co., Ltd. | 10/04/2024SE |
| K222487 | Anika Tissue Tack Fixation SystemGDW · Traditional | Anika Therapeutics, Inc. | 05/08/2023SE |
| K222210 | AEON Endoscopic StaplerGDW · Traditional | Lexington Medical, Inc. | 04/21/2023SE |
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR…GDW · Traditional | Ethicon Endo-Surgery | 03/15/2023SE |
More from Ethicon Endo-Surgery
| 510(k) | Device | Decision |
|---|---|---|
| K083527 | Intelligent Articulating Endoscopic Linear Cutter Reverse with ReloadsGDW · Special | 12/18/2008SE |
| K081826 | Intelligent Straight and Articular Endoscopic Linear Cutters, Vascular with Reloads…GDW · Special | 07/25/2008SE |
| K073001 | Idrives, Idrivec, IdrivefGDW · Special | 12/18/2007SE |
| K073148 | Idrives, Idrivec, Idrivef with Vascular IndicationsGDW · Special | 12/07/2007SE |
| K071708 | I45, I45S, I60, and I60SGDW · Traditional | 09/27/2007SE |
| K063746 | Power Extenders Model# PEC200, PES200,PES200SGDW · Special | 01/12/2007SE |
| K063075 | Natural Orifice Linear Cutter Digital Loading UnitsGDW · Special | 11/02/2006SE |
| K061649 | Power Circular Stapler Digital Loading Unit with and Without SheathGDW · Special | 09/01/2006SE |
| K052910 | Power Right Angle Linear Cutter Digital Loading Unit with ReloadsGDW · Special | 11/07/2005SE |
| K052415 | Power Linear Cutter Reusable Digital Loading Units with ReloadsGDW · Special | 09/29/2005SE |
Questions and answers
When was Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent Surgical Instrument cleared by the FDA?
Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent Surgical Instrument (K091215) received a 510(k) decision of Substantially Equivalent on May 18, 2009, 21 days after the submission was received.
What is the product code of K091215?
The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.