Precise Barnd Pi Disposable Surgical Staples
FDA 510(k) K911252 · 3M Medical Products Group
510(k) numberK911252
Submission
- Device name
- Precise Barnd Pi Disposable Surgical Staples
- Applicant
- 3M Medical Products Group
St Paul, MN, US - Received
- March 21, 1991
- Decision date
- July 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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| K952121 | 3M Resin CementEMA · Traditional | 06/22/1995SE |
| K945726 | 3M(TM) Ear Impression MaterialESD · Traditional | 01/27/1995SE |
| K941718 | 3M Fluid Control System 8300 Cassette LoadHRX · Traditional | 10/07/1994SE |
| K934333 | 3M Red Dot 2237 Sticky Gel Monitoring ECG ElectrodeDRX · Traditional | 07/07/1994SE |
| K923222 | 3M Color Laser Imager, Model 979LMC · Traditional | 09/30/1992SE |
| K923075 | 3M Laser Imager Model 969LMC · Traditional | 09/23/1992SE |
| K912225 | 3M Digital Recording Automatic Film Handling UnitIXW · Traditional | 07/22/1991SE |
| K910092 | 3M Laser Imager XLLMC · Traditional | 04/08/1991SE |
Questions and answers
When was Precise Barnd Pi Disposable Surgical Staples cleared by the FDA?
Precise Barnd Pi Disposable Surgical Staples (K911252) received a 510(k) decision of Substantially Equivalent on July 25, 1991, 126 days after the submission was received.
What is the product code of K911252?
The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.