CP Medical Inc
FDA Regulatory Profile
CP Medical Inc appears in FDA public data with 3 recalls, 32 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0655-2020, Class II) was initiated on October 18, 2019. Its most recent 510(k) clearance was granted on March 26, 2018.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 32
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0655-2020 | Class II | Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)107909 | October 18, 2019 |
| Z-1027-2019 | Class II | Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: P | February 4, 2019 |
| Z-1872-2017 | Class II | PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Ste | February 2, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K173922 | C-PTFETM Surgical Suture | March 26, 2018 |
| K094028 | CP-FIBER (ORTHOFIBER) | March 18, 2010 |
| K072229 | MONOSWIFT | October 5, 2007 |
| K071550 | PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS | July 18, 2007 |
| K060987 | OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 | November 2, 2006 |
| K041894 | ORTHOFIBER | September 17, 2004 |
| K034062 | CP SLEEVE AND RIVER SLEEVE | January 30, 2004 |
| K024372 | CP MEDICAL BONE WAX | June 19, 2003 |
| K030786 | MONO-SWIFT | May 6, 2003 |
| K030351 | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE | March 28, 2003 |
| K023710 | VISORB SWIFT | January 17, 2003 |
| K022075 | DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5 | September 19, 2002 |
| K021311 | SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL | July 13, 2002 |
| K013975 | CP-SLEEVE | February 22, 2002 |
| K013964 | MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS | January 24, 2002 |
| K013274 | MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE | November 16, 2001 |
| K010621 | ACCU-SPACE ABSORBABLE SEEDING SPACERS | September 4, 2001 |
| K002190 | POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) | August 10, 2000 |
| K001184 | SILK, NONABSORBABLE, SURGICAL SUTURES, USP | June 23, 2000 |
| K001185 | POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP | June 23, 2000 |