Uniplain & Unichrom
FDA 510(k) K042287 · United Medical Industries Co. , Ltd.
510(k) numberK042287
Submission
- Device name
- Uniplain & Unichrom
- Applicant
- United Medical Industries Co. , Ltd.
Riyadh, Central Province, SA - Received
- August 24, 2004
- Decision date
- September 7, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K142656 | Surgical Gut SutureGAL · Special | Covidien | 01/29/2015SE |
| K072930 | Demetech Absorbable Surgical Suture Plain & Chromic GutGAL · Traditional | Demetech Corp. | 04/30/2008SE |
| 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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| 510(k) | Device | Decision |
|---|---|---|
| K072646 | UnicaproneGAM · Traditional | 11/07/2007SE |
| K072645 | UniglactinGAM · Traditional | 11/07/2007SE |
| K072644 | Unicryl QuickGAM · Traditional | 11/07/2007SE |
| K042288 | UnicrylGAM · Traditional | 12/27/2004SE |
| K042285 | Unicryl MNEW · Traditional | 12/10/2004SE |
| K042284 | UnimideGAR · Traditional | 12/03/2004SE |
| K042286 | Uniester CGAT · Traditional | 12/01/2004SE |
| K042283 | UniproGAW · Traditional | 12/01/2004SE |
| K042282 | UnisilkGAP · Traditional | 12/01/2004SE |
Questions and answers
When was Uniplain & Unichrom cleared by the FDA?
Uniplain & Unichrom (K042287) received a 510(k) decision of Substantially Equivalent on September 7, 2005, 379 days after the submission was received.
What is the product code of K042287?
The FDA product code is GAL – Suture, Absorbable, Natural, a Class II (moderate risk) device regulated under 21 CFR 878.4830.