Davol, Inc.
Cranston, RI, US
Davol, Inc. appears in FDA device records in Cranston, RI. FDA records list 32 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 32
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 32 510(k) clearances for Davol, Inc. between 1989 and 2003. The busiest year on record is 1992, with 8. The most recent is 2003, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1990 | 4 |
| 1991 | 6 |
| 1992 | 8 |
| 1993 | 4 |
| 1994 | 5 |
| 2000 | 1 |
| 2001 | 1 |
| 2003 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K031213 | AQUASENS FLUID MONITORING SYSTEM | HIG | Substantially Equivalent | |
| K030307 | DAVOL ARTHROVENT OUTFLOW TUBING | HRX | Substantially Equivalent | |
| K003323 | COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 | FTL | Substantially Equivalent | |
| K003790 | DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 | GCJ | Substantially Equivalent | |
| K931899 | DAVOL ATS | CAC | Substantially Equivalent | |
| K941334 | DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE | HET | Substantially Equivalent | |
| K921405 | DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP | HFG | Substantially Equivalent | |
| K935503 | DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET | HIF | Substantially Equivalent | |
| K926479 | BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM | GCJ | Substantially Equivalent | |
| K931552 | DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT | CAC | Substantially Equivalent | |
| K932327 | THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM | KDQ | Substantially Equivalent | |
| K930147 | SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY | GCJ | Substantially Equivalent | |
| K924144 | ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (CTR) | HRX | Substantially Equivalent | |
| K924592 | DAVOL KNOT PUSHER | GCJ | Substantially Equivalent | |
| K914119 | DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | |
| K922526 | DAVOL LAPAROSCOPIC LOOP AND RETRIEVAL DEVICES | GCJ | Substantially Equivalent | |
| K920659 | DAVOL ENDO-FLO LASER PROBE AND ACCESSORIES | GEX | Substantially Equivalent | |
| K914755 | DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT | GCA | Unknown | |
| K915536 | DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC | GCY | Substantially Equivalent | |
| K915406 | DAVOL ELECTROSUGICAL PROBES | HFG | Substantially Equivalent | |
| K914910 | DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE) | GEI | Substantially Equivalent | |
| K914526 | DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY) | GCJ | Substantially Equivalent | |
| K913684 | DAVOL POST-OP AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | |
| K913028 | ARTHRO-FLOW IRRIGATION 2 SYSTEM | HRX | Substantially Equivalent | |
| K911205 | ARTHROSCOPY INSTRUMENT CANNULA | HRX | Substantially Equivalent | |
| K905448 | THORA-KLEX CHEST DRAINAGE UNIT | GCX | Substantially Equivalent | |
| K910340 | LAPAROSCOPIC ASPIRATION PROBE | HET | Substantially Equivalent | |
| K905016 | PEDIATRIC AND INFANT CATH KITS | FFH | Unknown | |
| K902722 | BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM | HET | Substantially Equivalent | |
| K901401 | DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM | CAC | Substantially Equivalent | |
| K896127 | THORA-KLEX CHEST DRAINAGE UNIT | KDQ | Substantially Equivalent | |
| K894990 | DAVOL ARTHROSCOPY CANNULA | HRX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CACApparatus, Autotransfusion
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- HRXArthroscope
- GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- KDQBottle, Collection, Vacuum
- HFGCoagulator, Laparoscopic, Unipolar (And Accessories)
- FFHCollector, Urine, Pediatric, For Indwelling Catheter
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HIGInsufflator, Hysteroscopic
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- FTLMesh, Surgical, Polymeric
- GEXPowered Laser Surgical Instrument
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain