510(k) K964879
- Device
- PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM
- Applicant
- DAVOL, INC., SUB. C.R. BARD, INC.
- 510(k) number
- K964879
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-03-04
- Date received
- 1996-12-05
- Regulation
- 888.1100
- Classification name
- Arthroscope
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBIN DRAGO
- Address
- 100 Sockanossett Crossroad Canston RI US 02920 02920
FDA Registration Numbers#
- 3005820796
- 1221485
- 9617601
- 1526611
- 3006946348
- 3015316279
- 3011373951
- 3013404959
- 8040700
- 1423395
- 3013700547
- 3007113251
- 3010400367
- 3008110533
- 2020601
- 3025318945
- 2936485
- 2032521
- 1421101
- 9681191
- 1054241
- 3008868758
- 2245304
- 1928237
- 3014725904
- 3010097171
- 3016667340
- 1032347
- 3010120148
- 3009538961
- 9611665
- 3008959444
- 1220477
- 3009888740
- 3008583793
- 9614434
- 3010273872
- 3011163668
- 3018242561
- 3009417901
- 9617616
- 2085947
- 2032677
- 2084346
- 3011230048
- 3006142527
- 1528668
- 1422078
- 1061124
- 3015967359
- 3009704301
- 3030733800
- 2320762
- 3004215117
- 3020746799
- 2916714
- 3002807310
- 1834331
- 3002808022
- 1030489
- 3005528784
- 1424263
- 3011024991
- 9614841
- 2434839
- 3015219237
- 3012818475
- 3011543740
- 3013176080
- 3014202166
- 3035366890
- 9681477
- 3014388471
- 2032098
- 3006524618
- 3016099036
- 3004464325
- 2650143
- 3006561161
Source Documents#
Other 510(k) Records For Product Code HRX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253523 | Freedom DS™ Decompression System | Spinal Simplicity | 2026-04-16 |
| K252546 | VantageTM Lumbar Decompression Kit | Allevion Medical, LLC | 2026-03-12 |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) | Medimaging Integrated Solution, Inc (Miis) | 2025-12-23 |
| K250795 | PUREVUE™ FMS | W.O.M. World of Medicine GmbH | 2025-12-05 |
| K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC | 2025-11-21 |
| K252458 | Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange Medtech Co., Ltd. | 2025-11-03 |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Hand Biomechanics Lab, Inc. | 2025-10-15 |
| K252594 | UltraGuideCTR® image guided soft tissue release system | Sonex Health | 2025-09-29 |
| K243774 | ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations | 2025-08-27 |
| K241990 | SpineSite Endoscope System | Hydrocision, Inc. | 2025-07-30 |
| K243602 | Arthrex Spine Endoscope | Arthrex, Inc. | 2025-05-16 |
| K242417 | VECTR – Video Endoscopic Carpal Tunnel Release System | Rafael Medical Devices, LLC | 2024-12-11 |
| K243020 | MIDASVu | Intravu, Inc. | 2024-12-02 |
| K233800 | Vertos mild Device Kit (MDK-0002) | Vertos Medical, Inc. | 2024-05-06 |
| K240535 | Digital ClarusScope System; Digital NeuroPEN System | Clarus Medical, LLC | 2024-04-25 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases