Company ยท US
Demetech Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2020. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 3 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 3 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 |
| FXX | Mask, Surgical | 1 |
| GAL | Suture, Absorbable, Natural | 1 |
| GAP | Suture, Nonabsorbable, Silk | 1 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 1 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 |
| KGI | Densitometer, Bone | 1 |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2020 | K201479 | DemeMASK Demetech Corporation | FXX |
| Nov 7, 2019 | K191361 | DemeDIOX Barbed Absorbable Surgical Suture Demetech Corporation | NEW |
| Jul 31, 2019 | K190777 | DemeTECH DemeFORCE Nonabsorbable Surgical Suture Demetech Corporation | GAT |
| Oct 11, 2018 | K181578 | DemeTECH PTFE Nonabsorbable Surgical Suture Demetech Corporation | NBY |
| Aug 27, 2018 | K181582 | DemeTECH DemeDIOX absorbable surgical suture Demetech Corporation | NEW |
| Sep 25, 2014 | K141007 | DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE Demetech Corp. | GAQ |
| May 30, 2014 | K123940 | DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE Demetech Corp. | GAM |
| Jul 17, 2013 | K130083 | DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE Demetech Corp. | GAM |
| Jan 8, 2010 | K082097 | DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE Demetech Corp. | NEW |
| Apr 30, 2008 | K072930 | DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT Demetech Corp. | GAL |
| May 16, 2005 | K043330 | POLYPROPILENE SURGICAL SUTURES Demetech Corp. | GAW |
| Apr 6, 2005 | K043539 | DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES Demetech Corp. | GAM |
| May 5, 2004 | K033550 | DXL CALSCAN Demetech AB, SE | KGI |
| Jun 18, 2003 | K023030 | DEMETECH POLYESTER NONABSORBABLE SUTURE Demetech Corp. | GAT |
| Jun 18, 2003 | K023028 | DEMETECH NYLON NONABSORBABLE SUTURE Demetech Corp. | GAR |
| Nov 25, 2002 | K023029 | DEMETECH SILK NONABSORBABLE SUTURE Demetech Corp. | GAP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||