Surgical Gut Suture
FDA 510(k) K142656 · Covidien
510(k) numberK142656
Submission
- Device name
- Surgical Gut Suture
- Applicant
- Covidien
North Haven, CT, US - Received
- September 18, 2014
- Decision date
- January 29, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAL – Suture, Absorbable, Natural
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4830
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072930 | Demetech Absorbable Surgical Suture Plain & Chromic GutGAL · Traditional | Demetech Corp. | 04/30/2008SE |
| K042287 | Uniplain & UnichromGAL · Traditional | United Medical Industries Co. , Ltd. | 09/07/2005SE |
| K042897 | Autobahn Tissue Closure Device and Disposable CartridgeGAL · Traditional | Ethicon Endo-Surgery, Inc. | 11/19/2004SE |
| K030227 | Suturtek Fastclose Suturing DeviceGAL · Traditional | Suturtek Incorporated | 03/17/2003SE |
| K020597 | SerralgutGAL · Traditional | Serral, S.A. DE C.V. | 08/14/2002SE |
| K021043 | Grams Absorbable Surgical Gut Suture Plain & ChromicGAL · Traditional | Gramsmed, LLC | 06/21/2002SE |
| K011105 | Suturtek Fastclose Fascia Closure DeviceGAL · Traditional | Qrc Consulting | 05/30/2001SE |
| K001299 | Plain and Chromic Gut Absorbable Surgical Sutures UspGAL · Traditional | Cp Medical | 06/23/2000SN |
| K000542 | Plain and Chronic Gut Absorbable Surgical Sutures, UspGAL · Traditional | Arc Medical Supplies (Beijing) Co, Ltd. | 04/28/2000SE |
| K993695 | Liga-Loop Suture ApplicatorGAL · Traditional | Hysterx, Inc. | 04/13/2000SE |
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Questions and answers
When was Surgical Gut Suture cleared by the FDA?
Surgical Gut Suture (K142656) received a 510(k) decision of Substantially Equivalent on January 29, 2015, 133 days after the submission was received.
What is the product code of K142656?
The FDA product code is GAL – Suture, Absorbable, Natural, a Class II (moderate risk) device regulated under 21 CFR 878.4830.