Davol Inc., Sub. C. R. Bard, Inc.: FDA clearances and approvals
Davol Inc., Sub. C. R. Bard, Inc. has 24 FDA 510(k) clearances (first 1994, latest 2010), plus 1 PMA decision, across 9 product codes in 4 review panels. Median 510(k) review time: 87 days. openFDA lists 32 product recalls by a recalling firm named Davol Inc., Sub. C. R. Bard, Inc.
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 |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 8 | 8 |
| HIG | Insufflator, Hysteroscopic | 5 | 5 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| HRX | Arthroscope | 3 | 3 |
| GDW | Staple, Implantable | 2 | 2 |
| FQH | Lavage, Jet | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| LMF | Agent, Absorbable Hemostatic, Collagen Based | 1 | 0 |
Review panels
Most recent Davol Inc., Sub. C. R. Bard, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101851 | VENTRALIGHT ST MESH | FTL | 2010-07-15 | 14 |
| K092032 | BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 | FTL | 2009-12-08 | 155 |
| K081010 | BARD 3DMAX MESH | FTL | 2008-10-07 | 181 |
| K061754 | BARD COMPOSITE L/P MESH | FTL | 2006-10-23 | 124 |
| K061314 | BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH | FTL | 2006-06-02 | 22 |
| K051848 | SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 | GDW | 2005-08-11 | 35 |
| K050610 | SALUTE FIXATION SYSTEM | GDW | 2005-05-25 | 76 |
| K011069 | AQUASENS FLUID MONITORING SYSTEM | HIG | 2001-08-16 | 129 |
| K003674 | NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, NEEDLE TIP, BALL TIP | GEI | 2000-12-08 | 9 |
| K991799 | DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO | HIG | 1999-09-13 | 110 |
14 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N17600 | PMA | AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT) | 1976-08-26 |
Recalls
32 product recalls in 13 recall events; 0 initiated in the last five years. Most recent: 2011-10-04.
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 Davol Inc., Sub. C. R. Bard, Inc. have?
Davol Inc., Sub. C. R. Bard, Inc. has 24 FDA 510(k) clearances (first 1994, latest 2010), plus 1 PMA decision, across 9 product codes in 4 review panels.
How long does FDA take to clear Davol Inc., Sub. C. R. Bard, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Davol Inc., Sub. C. R. Bard, Inc.'s cleared 510(k)s is 87 days.
What devices does Davol Inc., Sub. C. R. Bard, Inc. make?
Its most frequent FDA product codes are FTL (Mesh, Surgical, Polymeric, 8); HIG (Insufflator, Hysteroscopic, 5); GCJ (Laparoscope, General & Plastic Surgery, 3).
Has Davol Inc., Sub. C. R. Bard, Inc. had device recalls?
openFDA lists 32 product recalls in 13 recall events by a recalling firm whose name matches Davol Inc., Sub. C. R. Bard, Inc; the most recent began 2011-10-04. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 24 Davol Inc., Sub. C. R. Bard, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FTL, Davol Inc., Sub. C. R. Bard, Inc.'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.