Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgical Specialties Corp. Dba Angiotech · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
16 daysmedian FDA review time
45 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133420 | TRANQUILL BARBED DEVICE | Surgical Specialties Corp. Dba Angiotech | 2013-11-29 | 21 | 0 |
| K131224 | SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE | Surgical Specialties Corp. Dba Angiotech | 2013-05-16 | 16 | 0 |
| K130078 | QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE | Surgical Specialties Corp. Dba Angiotech | 2013-02-28 | 45 | 0 |
| K123877 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESI | Surgical Specialties Corp. Dba Angiotech | 2013-01-02 | 16 | 0 |
| K123836 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP | Surgical Specialties Corp. Dba Angiotech | 2012-12-21 | 8 | 0 |
| K123409 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP | Surgical Specialties Corp. Dba Angiotech | 2012-11-20 | 15 | 0 |
| K122898 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP | Surgical Specialties Corp. Dba Angiotech | 2012-10-22 | 31 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda