Company · US
Davol, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2025. Name variants (Inc, Corp, punctuation) are merged.
50510(k) clearances (0 in 12 months)
8recalls (1 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 9 |
| FTL | Mesh, Surgical, Polymeric | 8 |
| CAC | Apparatus, Autotransfusion | 5 |
| HRX | Arthroscope | 5 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 4 |
| HET | Laparoscope, Gynecologic (And Accessories) | 3 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 |
| HFG | Coagulator, Laparoscopic, Unipolar (And Accessories) | 2 |
| KDQ | Bottle, Collection, Vacuum | 2 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 |
| BYY | Tube, Aspirating, Flexible, Connecting | 1 |
| DYB | Introducer, Catheter | 1 |
| FFH | Collector, Urine, Pediatric, For Indwelling Catheter | 1 |
| FMF | Syringe, Piston | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 |
| GEX | Powered Laser Surgical Instrument | 1 |
| GFD | Dermatome | 1 |
| HIF | Insufflator, Laparoscopic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 12, 2025 | K251557 | Bard® Mesh; Bard® Mesh Pre-Shaped Davol, Inc. | FTL |
| Apr 9, 2025 | K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped Davol, Inc. | FTL |
| Apr 30, 2003 | K031213 | AQUASENS FLUID MONITORING SYSTEM Davol, Inc. | HIG |
| Feb 13, 2003 | K030307 | DAVOL ARTHROVENT OUTFLOW TUBING Davol, Inc. | HRX |
| Jan 22, 2001 | K003323 | COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 Davol, Inc. | FTL |
| Dec 22, 2000 | K003790 | DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 Davol, Inc. | GCJ |
| Nov 15, 1994 | K931899 | DAVOL ATS Davol, Inc. | CAC |
| Jun 14, 1994 | K941334 | DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE Davol, Inc. | HET |
| Mar 25, 1994 | K921405 | DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP Davol, Inc. | HFG |
| Mar 7, 1994 | K935503 | DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET Davol, Inc. | HIF |
| Mar 1, 1994 | K926479 | BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM Davol, Inc. | GCJ |
| Oct 8, 1993 | K931552 | DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT Davol, Inc. | CAC |
| Jul 13, 1993 | K932327 | THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM Davol, Inc. | KDQ |
| Jun 22, 1993 | K930147 | SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY Davol, Inc. | GCJ |
| Apr 8, 1993 | K924144 | ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (CTR) Davol, Inc. | HRX |
| Dec 17, 1992 | K924592 | DAVOL KNOT PUSHER Davol, Inc. | GCJ |
| Dec 3, 1992 | K914119 | DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM Davol, Inc. | CAC |
| Oct 23, 1992 | K921755 | 8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS Davol, Inc. | LJS |
| Sep 2, 1992 | K922526 | DAVOL LAPAROSCOPIC LOOP AND RETRIEVAL DEVICES Davol, Inc. | GCJ |
| Jun 5, 1992 | K920659 | DAVOL ENDO-FLO LASER PROBE AND ACCESSORIES Davol, Inc. | GEX |
| Mar 30, 1992 | K914755 | DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT Davol, Inc. | GCA |
| Mar 26, 1992 | K915536 | DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC Davol, Inc. | GCY |
| Feb 28, 1992 | K915406 | DAVOL ELECTROSUGICAL PROBES Davol, Inc. | HFG |
| Jan 6, 1992 | K914910 | DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE) Davol, Inc. | GEI |
| Nov 22, 1991 | K914526 | DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY) Davol, Inc. | GCJ |
| Nov 15, 1991 | K913684 | DAVOL POST-OP AUTOTRANSFUSION SYSTEM Davol, Inc. | CAC |
| Oct 31, 1991 | K913235 | DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH Davol, Inc. | FMF |
| Oct 10, 1991 | K913028 | ARTHRO-FLOW IRRIGATION 2 SYSTEM Davol, Inc. | HRX |
| Sep 18, 1991 | K912702 | PLASTIC ATTACHABLE DUAL PORT Davol, Inc. | LJT |
| Jun 17, 1991 | K911205 | ARTHROSCOPY INSTRUMENT CANNULA Davol, Inc. | HRX |
| Apr 19, 1991 | K910486 | 8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER Davol, Inc. | LJS |
| Mar 27, 1991 | K905448 | THORA-KLEX CHEST DRAINAGE UNIT Davol, Inc. | GCX |
| Feb 26, 1991 | K910340 | LAPAROSCOPIC ASPIRATION PROBE Davol, Inc. | HET |
| Feb 11, 1991 | K904558 | DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL Davol, Inc. | FOZ |
| Dec 20, 1990 | K905016 | PEDIATRIC AND INFANT CATH KITS Davol, Inc. | FFH |
| Nov 16, 1990 | K902722 | BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM Davol, Inc. | HET |
| Oct 23, 1990 | K901401 | DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM Davol, Inc. | CAC |
| Oct 22, 1990 | K903530 | PERCUTANEOUS INTRODUCERS Davol, Inc. | DYB |
| Jan 24, 1990 | K896127 | THORA-KLEX CHEST DRAINAGE UNIT Davol, Inc. | KDQ |
| Nov 8, 1989 | K894990 | DAVOL ARTHROSCOPY CANNULA Davol, Inc. | HRX |
| Jan 28, 1980 | K800081 | DAVOL/ABAMSON SILICONE SUMP DRAIN Davol, Inc. | GCY |
| Dec 6, 1979 | K792332 | DAVOL/SIMON DERMATOME Davol, Inc. | GFD |
| Nov 27, 1979 | K792281 | USHER'S MARLEX TUBULAR MESH Davol, Inc. | FTL |
| Aug 3, 1979 | K791306 | ELLIK EVACUATOR Davol, Inc. | KQT |
| Jul 24, 1979 | K791137 | SINGLE USE MONOPOLAR HAND CONTROL PENCIL Davol, Inc. | GEI |
| Dec 20, 1978 | K782028 | ROUND SILICONE DRAIN Davol, Inc. | GCY |
| Dec 20, 1978 | K782027 | HYSTERECTOMY T DRAIN Davol, Inc. | JOL |
| Dec 12, 1978 | K782026 | FLAT SILICONE DRAIN Davol, Inc. | GCY |
| Jun 2, 1978 | K780724 | BUBBLE SUCTION TUBING Davol, Inc. | BYY |
| Dec 20, 1977 | K772292 | T-TUBE WHELAN-MOSS Davol, Inc. | GCA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2026 | Davol, Inc. Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030. Open, Classified |
LMF | None listed |
| Jul 27, 2023 | Davol, Inc. Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficienci Open, Classified |
FTL | K130968 |
| Jul 27, 2023 | Davol, Inc. Ventralight ST w Echo PS 4.5" Circle
A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencie Open, Classified |
FTL | K130968 |
| Jul 27, 2023 | Davol, Inc. Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficien Open, Classified |
FTL | K130968 |
| Jul 27, 2023 | Davol, Inc. Ventralight ST 4" x 6" Ellipse with Echo PS
Catalog Number: 5955460 Open, Classified |
FTL | K130968 |
| Jun 27, 2022 | Davol, Inc. X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000) Open, Classified |
GCJ | K003790 |
| Jun 7, 2022 | Davol, Inc. HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey
SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction
and Irrigation Tubing, Catalog Number 0026870 Open, Classified |
GCJ | K961492 |
| Jun 7, 2022 | Davol, Inc. HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey
SmokEvac Trumpet Valve, Handle only, with Cojoined
Suction and Irrigation Tubing, Catalog number 0026880 Open, Classified |
GCJ | K961492 |