Genzyme Surgical Product (Genzyme Biosurgery): FDA clearances and approvals
Genzyme Surgical Product (Genzyme Biosurgery) has 9 FDA 510(k) clearances (first 1998, latest 2000), across 7 product codes in 2 review panels. Median 510(k) review time: 88 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | 2 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | 2 |
| CAC | Apparatus, Autotransfusion | 1 | 1 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| MDM | Instrument, Manual, Surgical, General Use | 1 | 1 |
| MOP | Rotator, Prosthetic Heart Valve | 1 | 1 |
Review panels
Most recent Genzyme Surgical Product (Genzyme Biosurgery) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001440 | NEXTSTITCH CARDIOVASCULAR VALVE SUTURE | GAT | 2000-11-13 | 189 |
| K001434 | 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE | GAT | 2000-06-12 | 35 |
| K992088 | BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE | GAM | 1999-09-03 | 74 |
| K991416 | ENDOSCOPIC CAMERA | GCJ | 1999-07-20 | 88 |
| K991191 | BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE | GAM | 1999-06-22 | 75 |
| K990062 | SAPHLIFT | MDM | 1999-03-30 | 81 |
| K982712 | RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 | CAC | 1998-12-18 | 136 |
| K980016 | MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE | MOP | 1998-08-07 | 217 |
| K981322 | CUTALON NYLON POLYAMIDE SURGICAL SUTURE | GAR | 1998-07-07 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Genzyme Surgical Product (Genzyme Biosurgery).
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Genzyme Surgical Product (Genzyme Biosurgery) have?
Genzyme Surgical Product (Genzyme Biosurgery) has 9 FDA 510(k) clearances (first 1998, latest 2000), across 7 product codes in 2 review panels.
How long does FDA take to clear Genzyme Surgical Product (Genzyme Biosurgery)'s 510(k)s?
The median time from FDA receipt to decision across Genzyme Surgical Product (Genzyme Biosurgery)'s cleared 510(k)s is 88 days.
What devices does Genzyme Surgical Product (Genzyme Biosurgery) make?
Its most frequent FDA product codes are GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 2); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 2); CAC (Apparatus, Autotransfusion, 1).
Has Genzyme Surgical Product (Genzyme Biosurgery) had device recalls?
openFDA lists no recalls under a recalling firm name matching Genzyme Surgical Product (Genzyme Biosurgery). Related entities may recall under other names.
Next steps
- See all 9 Genzyme Surgical Product (Genzyme Biosurgery) clearances with predicates and recalls
- Run predicate analysis for product code GAM, Genzyme Surgical Product (Genzyme Biosurgery)'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.