SURGICAL SPECIALTIES
FDA Regulatory Profile
SURGICAL SPECIALTIES appears in FDA public data with 1 recall, 31 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1534-2024, Class II) was initiated on March 26, 2024. Its most recent 510(k) clearance was granted on July 18, 2014.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 31
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1534-2024 | Class II | POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N | March 26, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K141625 | POLYSYN SURGICAL SUTURE | July 18, 2014 |
| K141558 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE | July 11, 2014 |
| K140227 | MONODERM SURGICAL SUTURE | February 28, 2014 |
| K080985 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO) | April 23, 2008 |
| K080680 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE | March 21, 2008 |
| K071989 | QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL | August 6, 2007 |
| K072028 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM | August 3, 2007 |
| K063680 | SHARPOINT PDO (POLYDIOXANONE) SUTURES | May 9, 2007 |
| K053380 | CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE | January 18, 2006 |
| K052962 | OPTIMIZED BARB DESIGN | December 6, 2005 |
| K052437 | MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE | November 7, 2005 |
| K050548 | CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS | April 1, 2005 |
| K050292 | SHARPOINT LUKENS BONE WAX | March 9, 2005 |
| K050247 | CONTOUR NECKLIFT THREADS | March 4, 2005 |
| K042856 | CONTOUR FOREHEAD/BROWLIFT THREAD | December 3, 2004 |
| K041593 | FEATHERLIFT EXTENDED LENGTH APTOS THREAD | September 20, 2004 |
| K040477 | MONODERM | May 18, 2004 |
| K020882 | SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG | July 26, 2002 |
| K014021 | SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED | January 28, 2002 |
| K003015 | SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD | December 15, 2000 |