Grieshaber Snare Instrument and Snare Cartridge
FDA 510(k) K914588 · Grieshaber & Co.
510(k) numberK914588
Submission
- Device name
- Grieshaber Snare Instrument and Snare Cartridge
- Applicant
- Grieshaber & Co.
Langhorne, PA, US - Received
- October 16, 1991
- Decision date
- June 11, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GAW – Suture, Nonabsorbable, Synthetic, Polypropylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5010
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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|---|---|---|---|
| K253572 | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX…GAW · Traditional | ETHICON, Inc. | 03/27/2026SE |
| K233355 | Cypris eXact Suturing SystemGAW · Traditional | Cypris Medical | 01/12/2024SE |
| K230746 | Non absorbable Surgical Polypropylene SutureGAW · Traditional | Shandong Haidike Medical Products Co., Ltd. | 09/14/2023SE |
| K221280 | VessealGAW · Traditional | Lydus Medical , Ltd. | 12/09/2022SE |
| K211178 | DURAMESH Mesh SutureGAW · Traditional | Msi | 09/02/2022SE |
| K192953 | APTOS Threads Polypropylene Surgical SuturesGAW · Traditional | Aptos, LLC | 08/27/2020SE |
| K193530 | Deklene MAXXGAW · Special | Teleflex Medical | 03/19/2020SE |
| K191299 | Silhouette Featherlift / Silhouette LiftGAW · Special | Silhouette Lift, Inc. | 06/14/2019SE |
| K173747 | RexleneGAW · Traditional | Sm Eng Co., Ltd. | 12/21/2018SE |
| K180321 | Aesculap Optilene Nonabsorbable SutureGAW · Special | Aesculap, Inc. | 03/07/2018SE |
More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K950056 | The Grieshaber Axial CutterHKP · Traditional | 05/05/1995SE |
| K930842 | The Grieshaber Syst/Ai Tubing Set and CartridgeHQE · Traditional | 05/03/1994SE |
| K914587 | Grieshaber Air/Fluid Tubing SetKYG · Traditional | 01/23/1992SE |
| K914586 | Grieshaber Three Function ManipulatorEQH · Traditional | 01/03/1992SE |
| K914585 | Grieshaber Two Function ManipulatorEQH · Traditional | 01/03/1992SE |
| K897119 | Grieshaber Retinal Tack and Sutherland Tack ForcepHQW · Traditional | 04/12/1990SE |
| K900714 | Zzipp Instant Bovie CleanerGEI · Traditional | 03/27/1990SE |
| K890782 | Grieshaber Soft Tip Needle (20 & 19 Gauges)HMX · Traditional | 06/23/1989SE |
| K890783 | Grieshaber Viscoelastic Injection SystemFRN · Traditional | 05/16/1989SE |
| K884043 | Grieshaber Micro Lite Light Pipe 19 & 20 GaugeHQE · Traditional | 11/16/1988SE |
Questions and answers
When was Grieshaber Snare Instrument and Snare Cartridge cleared by the FDA?
Grieshaber Snare Instrument and Snare Cartridge (K914588) received a 510(k) decision of Substantially Equivalent on June 11, 1992, 239 days after the submission was received.
What is the product code of K914588?
The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.