Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Genzyme Surgical Product (Genzyme Biosurgery) · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
217 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001440 | NEXTSTITCH CARDIOVASCULAR VALVE SUTURE | Genzyme Surgical Product (Genzyme Biosurgery) | 2000-11-13 | 189 | 1 |
| K001434 | 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER | Genzyme Surgical Product (Genzyme Biosurgery) | 2000-06-12 | 35 | 1 |
| K992088 | BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL | Genzyme Surgical Product (Genzyme Biosurgery) | 1999-09-03 | 74 | 6 |
| K991416 | ENDOSCOPIC CAMERA | Genzyme Surgical Product (Genzyme Biosurgery) | 1999-07-20 | 88 | 0 |
| K991191 | BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUR | Genzyme Surgical Product (Genzyme Biosurgery) | 1999-06-22 | 75 | 1 |
| K990062 | SAPHLIFT | Genzyme Surgical Product (Genzyme Biosurgery) | 1999-03-30 | 81 | 0 |
| K982712 | RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD | Genzyme Surgical Product (Genzyme Biosurgery) | 1998-12-18 | 136 | 0 |
| K980016 | MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE | Genzyme Surgical Product (Genzyme Biosurgery) | 1998-08-07 | 217 | 0 |
| K981322 | CUTALON NYLON POLYAMIDE SURGICAL SUTURE | Genzyme Surgical Product (Genzyme Biosurgery) | 1998-07-07 | 88 | 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