510(k) K991799
- Device
- DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO
- Applicant
- DAVOL, INC., SUB. C.R. BARD, INC.
- 510(k) number
- K991799
- Product code
- HIG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-09-13
- Date received
- 1999-05-26
- Regulation
- 884.1700
- Classification name
- Insufflator, Hysteroscopic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LUCINDA L FOX
- Address
- 100 Sockanossett Crossroad Canston RI US 02920 02920
FDA Registration Numbers#
- 3006131984
- 3014279513
- 9614434
- 1220477
- 1221826
- 3005382983
- 3010273872
- 3007495879
- 3042158861
- 3008837339
- 3018094310
- 1526611
- 3013247477
- 3043236281
- 2954783
- 9680340
- 8043980
- 1216677
- 3007113251
- 3003542872
- 1424263
- 9710641
- 1423662
- 3009746061
- 9612445
- 3009538961
- 2020550
- 3005136445
- 2031963
- 2936485
- 3010707607
- 3016678045
- 3017616393
- 3013557562
- 3012322232
- 1222780
- 3020976354
- 3010202439
- 3010432890
- 2511556
- 3033043422
- 2246552
- 3007305485
- 3007200016
- 3008810357
- 3005099803
- 3011050570
- 3002907620
- 3001556604
- 3014461810
- 3015512350
- 2521453
- 2124215
- 9610617
- 3012356141
- 1219930
- 3004111573
- 3006330030
- 3003790304
- 9616693
- 3008044552
- 2953359
- 3011011193
- 9610773
- 9611102
- 3014342096
Source Documents#
Other 510(k) Records For Product Code HIG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251273 | Asurys Fluid Management System | Boston Scientific Corporation | 2026-03-27 |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) | Hologic, Inc. | 2024-07-25 |
| K210628 | X-FLO Fluid Management System | Thermedx, LLC | 2021-11-04 |
| K201355 | Endomat Select, IBS Shaver Software, License | Karl Storz SE & CO. KG | 2020-07-22 |
| K180735 | Endomat Select | Karl Storz SE & CO. KG | 2018-10-31 |
| K180825 | Fluent Fluid Management System | Hologic, Inc. | 2018-08-03 |
| K173489 | GYN-Pump PH304 | W.O.M. World of Medicine GmbH | 2018-03-28 |
| K172040 | Aquilex Fluid Control System AQL-100S | W.O.M. World of Medicine GmbH | 2018-02-05 |
| K172048 | FluidSmart | Thermedx, LLC | 2017-09-05 |
| K133799 | THERMEDX FLUID MANAGMENT SYSTEM | Thermedx, LLC | 2014-06-20 |
| K123732 | HYSTEROSCOPY PUMP HM6 | W.O.M. World of Medicine AG | 2013-04-04 |
| K112642 | AQUILEX FLUID CONTROL SYSTEM H112 | W.O.M. World of Medicine AG | 2012-02-06 |
| K110852 | DOLPHIN 3 FLUID MANAGEMENT SYSTEM | Gyrus Acmi, Inc. | 2011-07-19 |
| K091939 | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 | Thermedx, LLC | 2010-07-23 |
| K031616 | IUR FLUID MANAGEMENT SYSTEM | W.O.M. World of Medicine AG | 2003-08-13 |
Legacy Summary#
summary
FDA Review#
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