Sterile Plain Gut/Chromic Gut Absorb Surg Sutures
FDA 510(k) K911354 · Internacional Farmaceutica, S.A. DE C.V.
510(k) numberK911354
Submission
- Device name
- Sterile Plain Gut/Chromic Gut Absorb Surg Sutures
- Applicant
- Internacional Farmaceutica, S.A. DE C.V.
Great Neck, NY, US - Received
- March 26, 1991
- Decision date
- October 25, 1991
- Decision
- Substantially Equivalent (SESE)
- 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
Other 510(k)s with product code GAL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K072863 | Atramat PGC25 Poly(Glycolide-Co-Epsilon-Caprolactone) Surgical SuturesGAM · Traditional | 05/23/2008SE |
| K072859 | Atramat PGLA90 Poly(Glycolide-Co-L-Lactide) Surgical SuturesGAM · Traditional | 05/23/2008SE |
| K041048 | Polydioxanone Synthetic Absorbable Surgical SutureNEW · Traditional | 06/04/2004SE |
| K040282 | Atramat and Sorb-Fast Polyglycolic AcidGAM · Traditional | 04/29/2004SE |
| K913185 | Sterile Stainless Steel Monofil Nonabsorb Surg SutGAQ · Traditional | 12/04/1991SE |
| K911189 | Sterile Polypropylene Monfil Nonabsorb Surg SutureGAW · Traditional | 04/25/1991SE |
| K905287 | Ifsa Sterile Silk Braided Nonabsor Surg SuturesGAP · Traditional | 02/11/1991SE |
| K905286 | Ifsa Sterile Nlylon Monofil Nonabsor Surg SuturesGAR · Traditional | 02/11/1991SE |
| K905285 | Ifsa Sterile Braided Poly Nonabsor Surg SuturesGAS · Traditional | 02/11/1991SE |
Questions and answers
When was Sterile Plain Gut/Chromic Gut Absorb Surg Sutures cleared by the FDA?
Sterile Plain Gut/Chromic Gut Absorb Surg Sutures (K911354) received a 510(k) decision of Substantially Equivalent on October 25, 1991, 213 days after the submission was received.
What is the product code of K911354?
The FDA product code is GAL – Suture, Absorbable, Natural, a Class II (moderate risk) device regulated under 21 CFR 878.4830.