Micromark Clip
FDA 510(k) K970817 · Biopsys Medical, Inc.
510(k) numberK970817
Submission
- Device name
- Micromark Clip
- Applicant
- Biopsys Medical, Inc.
Irvine, CA, US - Received
- March 6, 1997
- Decision date
- September 11, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K970565 | Mammotome Biopsy Probe and Housing (Mammotome)KNW · Traditional | 03/28/1997SE |
| K963015 | Surgical Staple Marker Device (Modify)GDW · Traditional | 10/07/1996SE |
| K960019 | Retractor Arm ClampFWZ · Traditional | 02/09/1996SE |
| K953962 | ForcepsGEN · Traditional | 09/08/1995SE |
| K953880 | Biopsy NeedleKNW · Traditional | 09/08/1995SE |
| K951326 | Biopsy Device AccessoryBTA · Traditional | 05/15/1995SE |
| K951229 | Modified Biopsy NeedleKNW · Traditional | 04/06/1995SE |
| K950006 | Surgical Staple MarkerGDW · Traditional | 03/15/1995SE |
| K943863 | Needle GuideIYN · Traditional | 12/29/1994SE |
| K945573 | Biopsy Device AccessoryKNW · Traditional | 12/09/1994SE |
Questions and answers
When was Micromark Clip cleared by the FDA?
Micromark Clip (K970817) received a 510(k) decision of Substantially Equivalent on September 11, 1997, 189 days after the submission was received.
What is the product code of K970817?
The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.