Company ยท US
Lukens Medical Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 1997. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 |
| GAL | Suture, Absorbable, Natural | 1 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 1 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 1 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | 1 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 1997 | K965162 | LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. Lukens Medical Corp. | GAM |
| Dec 17, 1993 | K930945 | BRAIDED POLYESTER SURGICAL SUTURE Lukens Medical Corp. | GAT |
| Dec 17, 1993 | K930944 | LUKENS SURGICAL GUT SUTURE Lukens Medical Corp. | GAL |
| Dec 17, 1993 | K930943 | LUKENS NYLON SURGICAL SUTURE Lukens Medical Corp. | GAR |
| Dec 17, 1993 | K930942 | LUKENS SILK SURGICAL SUTURE Lukens Medical Corp. | GAT |
| Dec 17, 1993 | K930941 | LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE Lukens Medical Corp. | GAW |
| Dec 17, 1993 | K930940 | LUKENS STAINLESS STEEL SURGICAL SUTURE Lukens Medical Corp. | GAQ |
| Jan 30, 1991 | K904535 | LU-TEX II Lukens Medical Corp. | GAS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||