Grams Absorbable Surgical Gut Suture Plain & Chromic
FDA 510(k) K021043 · Gramsmed, LLC
510(k) numberK021043
Submission
- Device name
- Grams Absorbable Surgical Gut Suture Plain & Chromic
- Applicant
- Gramsmed, LLC
Grafton, WI, US - Received
- April 1, 2002
- Decision date
- June 21, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|---|
| 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 |
| 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 |
More from Hysterx, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K010672 | Monograms Synthetic Monofilament Absorbable SutureGAM · Traditional | 05/18/2001SE |
| K003017 | Gramsorb Synthetic Absorbable SutureGAM · Traditional | 03/13/2001SE |
| K003590 | Grams Polyester Nonabsorbable SutureGAT · Traditional | 03/05/2001SE |
| K003000 | Grams Nylon Nonabsorbable SutureGAR · Traditional | 12/18/2000SE |
| K002999 | Grams Polypropylene Nonabsorbable SutureGAW · Traditional | 12/18/2000SE |
| K003001 | Grams Silk Nonabsorbable SutureGAP · Traditional | 12/15/2000SE |
Questions and answers
When was Grams Absorbable Surgical Gut Suture Plain & Chromic cleared by the FDA?
Grams Absorbable Surgical Gut Suture Plain & Chromic (K021043) received a 510(k) decision of Substantially Equivalent on June 21, 2002, 81 days after the submission was received.
What is the product code of K021043?
The FDA product code is GAL – Suture, Absorbable, Natural, a Class II (moderate risk) device regulated under 21 CFR 878.4830.