Company ยท US
Cp Medical
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2018. Name variants (Inc, Corp, punctuation) are merged.
32510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | 6 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 5 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 3 |
| GAL | Suture, Absorbable, Natural | 2 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 2 |
| MTJ | Wax, Bone | 2 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 2 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 |
| EIB | Syringe, Irrigating (Dental) | 1 |
| FIB | Protector, Transducer, Dialysis | 1 |
| FPA | Set, Administration, Intravascular | 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 |
| GAX | Tourniquet, Nonpneumatic | 1 |
| HXD | Clamp | 1 |
| KGX | Tape And Bandage, Adhesive | 1 |
| KXM | System Accessories, Extracorporeal | 1 |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 26, 2018 | K173922 | C-PTFETM Surgical Suture Cp Medical, Inc. | NBY |
| Mar 18, 2010 | K094028 | CP-FIBER (ORTHOFIBER) Cp Medical | GAT |
| Oct 5, 2007 | K072229 | MONOSWIFT Cp Medical | GAM |
| Jul 18, 2007 | K071550 | PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS Cp Medical | KXK |
| Nov 2, 2006 | K060987 | OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 Cp Medical | MTJ |
| Sep 17, 2004 | K041894 | ORTHOFIBER Cp Medical | GAT |
| Jan 30, 2004 | K034062 | CP SLEEVE AND RIVER SLEEVE Cp Medical | KXK |
| Jun 19, 2003 | K024372 | CP MEDICAL BONE WAX Cp Medical | MTJ |
| May 6, 2003 | K030786 | MONO-SWIFT Cp Medical | NEW |
| Mar 28, 2003 | K030351 | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE Cp Medical | GAQ |
| Jan 17, 2003 | K023710 | VISORB SWIFT Cp Medical | GAM |
| Sep 19, 2002 | K022075 | DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5 Cp Medical | DSA |
| Jul 13, 2002 | K021311 | SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL Cp Medical | KXK |
| Feb 22, 2002 | K013975 | CP-SLEEVE Cp Medical | KXK |
| Jan 24, 2002 | K013964 | MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS Cp Medical | KXK |
| Nov 16, 2001 | K013274 | MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE Cp Medical | NEW |
| Sep 4, 2001 | K010621 | ACCU-SPACE ABSORBABLE SEEDING SPACERS Cp Medical | KXK |
| Aug 10, 2000 | K002190 | POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) Cp Medical | GAM |
| Jun 23, 2000 | K001299 | PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP Cp Medical | GAL |
| Jun 23, 2000 | K001185 | POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP Cp Medical | GAW |
| Jun 23, 2000 | K001184 | SILK, NONABSORBABLE, SURGICAL SUTURES, USP Cp Medical | GAP |
| Jun 23, 2000 | K001173 | NYLON, NONABSORBABLE SURGICAL SUTURES USP Cp Medical | GAR |
| Jun 23, 2000 | K001172 | POLYESTER NONABSORBABLE SURGICAL SUTURES URP Cp Medical | GAT |
| Jun 9, 1993 | K911230 | RS-1000 Cp Medical | KOC |
| Feb 11, 1992 | K913337 | INJECTION CAP Cp Medical | FPA |
| Nov 20, 1991 | K911118 | DTF-1000LL,DTF-1000 Cp Medical | EIB |
| Nov 25, 1985 | K854006 | PLASTELAST AND/OR ELASTOPLASTE Cp Medical | KGX |
| Oct 17, 1985 | K853536 | VELCRO FISTULA PRESSURE CLAMPS Cp Medical | KXM |
| Sep 12, 1985 | K853538 | CANNULA CLAMP Cp Medical | HXD |
| Sep 12, 1985 | K853537 | VELCRO TOURNIQUET Cp Medical | GAX |
| May 2, 1984 | K840654 | DIALYSIS ADMIN. SET - I.V. Cp Medical | KOC |
| Jun 23, 1982 | K821268 | TRANSDUCER FILTER Cp Medical | FIB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2019 | CP Medical Inc Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970 Open, Classified |
GAM | K002190 |
| Feb 4, 2019 | CP Medical Inc 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 Open, Classified |
GAL | K001299 |
| Feb 2, 2017 | CP Medical Inc 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 Open, Classified |
GAM | K072229 |