Plain and Chromic Gut Suture
FDA 510(k) K903624 · Look, Inc.
510(k) numberK903624
Submission
- Device name
- Plain and Chromic Gut Suture
- Applicant
- Look, Inc.
Ada, OK, US - Received
- August 8, 1990
- Decision date
- September 18, 1990
- 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
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 |
|---|---|---|
| K943949 | Polyviolene Surgicl SutureGAT · Traditional | 11/10/1994SN |
| K933686 | Look Inc. 316L Stainless Steel Surgical SutureGAQ · Traditional | 12/23/1993SE |
| K926586 | Revised Labeling for Chromic and Plain Gut SuturesGAL · Traditional | 12/22/1993SE |
| K926588 | Revised Labeling for Polypropylene SutureGAW · Traditional | 12/17/1993SE |
| K926587 | Revised Labeling for Nylon Suture (Polyamide)GAR · Traditional | 12/17/1993SE |
| K926168 | Silk Sutures-Revised LabelingGAR · Traditional | 12/17/1993SE |
| K926167 | Polyviolene Suture-Revised LabelingGAT · Traditional | 12/17/1993SE |
| K913530 | Look ViscodissectorHQC · Traditional | 10/21/1991SE |
| K903029 | Sterile Black Monofilament Nylon Non-Absor. SutureGAR · Traditional | 10/25/1990SE |
| K903584 | Polypropylene Nonabsorbable Surgical SuturesGAW · Traditional | 10/11/1990SE |
Questions and answers
When was Plain and Chromic Gut Suture cleared by the FDA?
Plain and Chromic Gut Suture (K903624) received a 510(k) decision of Substantially Equivalent for Some Indications on September 18, 1990, 41 days after the submission was received.
What is the product code of K903624?
The FDA product code is GAL – Suture, Absorbable, Natural, a Class II (moderate risk) device regulated under 21 CFR 878.4830.