GAL — Suture, Absorbable, Natural Class II
FDA product code GAL covers "Suture, Absorbable, Natural", a Class II medical device regulated under 21 CFR 878.4830. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GAL
- Device Class
- Class II
- Regulation Number
- 878.4830
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K142656 | covidien | Surgical Gut Suture | January 29, 2015 |
| K072930 | demetech | DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT | April 30, 2008 |
| K042287 | united medical industries co. | UNIPLAIN & UNICHROM | September 7, 2005 |
| K042897 | ethicon endo-surgery | AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE | November 19, 2004 |
| K030227 | suturtek incorporated | SUTURTEK FASTCLOSE SUTURING DEVICE | March 17, 2003 |
| K020597 | serral, s.a. de c.v | SERRALGUT | August 14, 2002 |
| K021043 | gramsmed | GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC | June 21, 2002 |
| K011105 | qrc consulting | SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE | May 30, 2001 |
| K001299 | cp medical | PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP | June 23, 2000 |
| K000542 | arc medical supplies (beijing) co | PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP | April 28, 2000 |
| K993695 | hysterx | LIGA-LOOP SUTURE APPLICATOR | April 13, 2000 |
| K994002 | trading consultants and distributors intl | PLAIN/CHROMIC CATGUT | February 4, 2000 |
| K982646 | myco medical supplies | AILEE SUTURES AND AILEE NEEDLES | June 2, 1999 |
| K991223 | aesculap | ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICA | April 30, 1999 |
| K961931 | r. k. medical l. l. c | PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP | July 29, 1996 |
| K943217 | sutures | PLAIN CATGUT | December 5, 1994 |
| K943218 | sutures | CHROMIC CATGUT | December 5, 1994 |
| K930738 | deknatel | SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC | July 26, 1994 |
| K930416 | united states surgical, a division of tyco healthc | SURGICAL SUTURE PACKAGE INSERTS | April 28, 1994 |
| K931918 | surgimetrics international | CATGUT SUTURE PLAIN | March 3, 1994 |