Chromic Catgut
FDA 510(k) K943218 · Sutures , Ltd.
510(k) numberK943218
Submission
- Device name
- Chromic Catgut
- Applicant
- Sutures , Ltd.
Ruabon, Wrexham, GB - Received
- July 5, 1994
- Decision date
- December 5, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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
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|---|---|---|---|
| K142656 | Surgical Gut SutureGAL · Special | Covidien | 01/29/2015SE |
| 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 |
More from Arc Medical Supplies (Beijing) Co, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K990432 | SurgisorbGAM · Traditional | 05/27/1999SN |
| K953609 | ProdekGAW · Traditional | 01/31/1996SN |
| K943627 | SurgisilkGAP · Traditional | 12/05/1994SN |
| K943223 | Surgidek BGAR · Traditional | 12/05/1994SN |
| K943222 | Surgidek SGAR · Traditional | 12/05/1994SN |
| K943221 | SurgibondGAT · Traditional | 12/05/1994SN |
| K943220 | SutuleneGAT · Traditional | 12/05/1994SN |
| K943217 | Plain CatgutGAL · Traditional | 12/05/1994SN |
| K943216 | SurgidekGAR · Traditional | 12/05/1994SN |
| K865038 | SurgisteelGAQ · Traditional | 06/30/1987SE |
Questions and answers
When was Chromic Catgut cleared by the FDA?
Chromic Catgut (K943218) received a 510(k) decision of Substantially Equivalent for Some Indications on December 5, 1994, 153 days after the submission was received.
What is the product code of K943218?
The FDA product code is GAL – Suture, Absorbable, Natural, a Class II (moderate risk) device regulated under 21 CFR 878.4830.