Sutures, Ltd.
Ruabon, Wrexham, GB
Sutures , Ltd. appears in FDA device records in Ruabon, Wrexham, GB. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Sutures, Ltd. between 1987 and 1999. The busiest year on record is 1994, with 8. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 1994 | 8 |
| 1996 | 1 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K990432 | SURGISORB | GAM | Substantially Equivalent for Some Indications | |
| K953609 | PRODEK | GAW | Substantially Equivalent for Some Indications | |
| K943627 | SURGISILK | GAP | Substantially Equivalent for Some Indications | |
| K943223 | SURGIDEK B | GAR | Substantially Equivalent for Some Indications | |
| K943222 | SURGIDEK S | GAR | Substantially Equivalent for Some Indications | |
| K943221 | SURGIBOND | GAT | Substantially Equivalent for Some Indications | |
| K943220 | SUTULENE | GAT | Substantially Equivalent for Some Indications | |
| K943218 | CHROMIC CATGUT | GAL | Substantially Equivalent for Some Indications | |
| K943217 | PLAIN CATGUT | GAL | Substantially Equivalent for Some Indications | |
| K943216 | SURGIDEK | GAR | Substantially Equivalent for Some Indications | |
| K865038 | SURGISTEEL | GAQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GALSuture, Absorbable, Natural
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- GAPSuture, Nonabsorbable, Silk
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- GARSuture, Nonabsorbable, Synthetic, Polyamide
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain