Atlas FDA

PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM

FDA 510(k) clearance K964879 · decided 1997-03-04

Clearance details

K-number
K964879
Device name
PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM
Applicant
Davol Inc., Sub. C. R. Bard, Inc.
Decision
Substantially Equivalent
Date received
1996-12-05
Decision date
1997-03-04
Days to decision
89 days
Clearance type
Traditional
Product code
HRX
Device class
2
Regulation number
888.1100
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Canston, RI, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Davol Inc.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Digital ClarusScope System and Digital NeuroPEN System (K252790)Clarus Medical, LLC2026-05-26
Freedom DS™ Decompression System (K253523)Spinal Simplicity2026-04-16
VantageTM Lumbar Decompression Kit (K252546)Allevion Medical, LLC2026-03-12
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) (K253217)Medimaging Integrated Solution, Inc (Miis)2025-12-23
PUREVUE™ FMS (K250795)W.O.M. World of Medicine GmbH2025-12-05
Articulator Arthroscopic Bur (K252666)Joint Preservation Innovations, LLC2025-11-21
Kyphoplasty Balloon Dilatation Catheters (K252458)Shanghai Lange Medtech Co., Ltd.2025-11-03
TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (K252020)Hand Biomechanics Lab, Inc.2025-10-15
UltraGuideCTR® image guided soft tissue release system (K252594)Sonex Health2025-09-29
ELID (Endoscopic Less Invasive Decompression) System (K243774)Lesspine Innovations2025-08-27
SpineSite Endoscope System (K241990)Hydrocision, Inc.2025-07-30
Arthrex Spine Endoscope (K243602)Arthrex, Inc.2025-05-16

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Avitene Flowable Collagen Hemostat (N17600/S043)Davol Inc., Sub. C. R. Bard, Inc.2025-06-10
Avitene™ Microfibrillar Collagen Hemostat (N17600/S044)Davol Inc., Sub. C. R. Bard, Inc.2025-05-20
Avitene Microfibrillar Collagen Hemostat (N17600/S042)Davol Inc., Sub. C. R. Bard, Inc.2025-03-13
AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT) (N17600/S041)Davol Inc., Sub. C. R. Bard, Inc.2025-02-18
Avitene Flowable Collagen Hemostat (N17600/S040)Davol Inc., Sub. C. R. Bard, Inc.2024-12-18
Avitene™ Microfibrillar Collagen Hemostat (MCH) (N17600/S039)Davol Inc., Sub. C. R. Bard, Inc.2024-01-18
Avitene™ Microfibrillar Collagen Hemostat (N17600/S037)Davol Inc., Sub. C. R. Bard, Inc.2023-10-04
Avitene™ Microfibrillar Collagen Hemostat (N17600/S038)Davol Inc., Sub. C. R. Bard, Inc.2023-04-25