Cp Medical
Portland, OR, US
Cp Medical appears in FDA device records in Portland, OR. FDA records list 32 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 32 510(k) clearances for Cp Medical between 1982 and 2018. The busiest year on record is 2000, with 6. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1984 | 1 |
| 1985 | 4 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 2000 | 6 |
| 2001 | 2 |
| 2002 | 4 |
| 2003 | 4 |
| 2004 | 2 |
| 2006 | 1 |
| 2007 | 2 |
| 2010 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K173922 | C-PTFETM Surgical Suture | NBY | Substantially Equivalent | |
| K094028 | CP-FIBER (ORTHOFIBER) | GAT | Substantially Equivalent | |
| K072229 | MONOSWIFT | GAM | Substantially Equivalent | |
| K071550 | PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS | KXK | Substantially Equivalent | |
| K060987 | OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 | MTJ | Substantially Equivalent | |
| K041894 | ORTHOFIBER | GAT | Substantially Equivalent | |
| K034062 | CP SLEEVE AND RIVER SLEEVE | KXK | Substantially Equivalent | |
| K024372 | CP MEDICAL BONE WAX | MTJ | Substantially Equivalent | |
| K030786 | MONO-SWIFT | NEW | Substantially Equivalent | |
| K030351 | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE | GAQ | Substantially Equivalent | |
| K023710 | VISORB SWIFT | GAM | Substantially Equivalent | |
| K022075 | DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5 | DSA | Substantially Equivalent | |
| K021311 | SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL | KXK | Substantially Equivalent | |
| K013975 | CP-SLEEVE | KXK | Substantially Equivalent | |
| K013964 | MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS | KXK | Substantially Equivalent | |
| K013274 | MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE | NEW | Substantially Equivalent | |
| K010621 | ACCU-SPACE ABSORBABLE SEEDING SPACERS | KXK | Substantially Equivalent | |
| K002190 | POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) | GAM | Substantially Equivalent for Some Indications | |
| K001299 | PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP | GAL | Substantially Equivalent for Some Indications | |
| K001185 | POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP | GAW | Substantially Equivalent for Some Indications | |
| K001184 | SILK, NONABSORBABLE, SURGICAL SUTURES, USP | GAP | Substantially Equivalent for Some Indications | |
| K001173 | NYLON, NONABSORBABLE SURGICAL SUTURES USP | GAR | Substantially Equivalent for Some Indications | |
| K001172 | POLYESTER NONABSORBABLE SURGICAL SUTURES URP | GAT | Substantially Equivalent for Some Indications | |
| K911230 | RS-1000 | KOC | Substantially Equivalent | |
| K913337 | INJECTION CAP | FPA | Substantially Equivalent | |
| K911118 | DTF-1000LL,DTF-1000 | EIB | Substantially Equivalent | |
| K854006 | PLASTELAST AND/OR ELASTOPLASTE | KGX | Substantially Equivalent | |
| K853536 | VELCRO FISTULA PRESSURE CLAMPS | KXM | Substantially Equivalent | |
| K853538 | CANNULA CLAMP | HXD | Substantially Equivalent | |
| K853537 | VELCRO TOURNIQUET | GAX | Substantially Equivalent | |
| K840654 | DIALYSIS ADMIN. SET - I.V. | KOC | Substantially Equivalent | |
| K821268 | TRANSDUCER FILTER | FIB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- HXDClamp
- FIBProtector, Transducer, Dialysis
- FPASet, Administration, Intravascular
- KXKSource, Brachytherapy, Radionuclide
- 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
- NEWSuture, Surgical, Absorbable, Polydioxanone
- NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- EIBSyringe, Irrigating (Dental)
- KXMSystem Accessories, Extracorporeal
- KGXTape And Bandage, Adhesive
- GAXTourniquet, Nonpneumatic
- MTJWax, Bone
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0655-2020 | Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970 | Failed to meet USP minimum average value for knot pull (tensile) strength. | Class II | Open, Classified | |
| Z-1027-2019 | Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues. | Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result. | Class II | Open, Classified | |
| Z-1872-2017 | PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493 | The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain