510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964879Substantially Equivalent

Pneumatic Arthroscopy Pulsed Irrigator System Model 0027030 and Battery Arthroscopy Pulsed Irrigator System

Davol Inc., Sub. C.R. Bard, Inc., Canston RI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964879 is the FDA 510(k) clearance record for PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM, a class II device, cleared for Davol Inc., Sub. C. R. Bard, Inc. on under FDA product code HRX (Arthroscope). FDA's definition for product code HRX reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 24 510(k) clearances for DAVOL INC., SUB. C.R. BARD, INC., from to . As of , FDA records show no recalls naming K964879.

Clearance record

Decision date
Received
(89 days to decision)
Product code
HRX Arthroscope
Regulation
21 CFR 888.1100
Device class
Class II
Review panel
Orthopedic
Applicant
Davol Inc., Sub. C. R. Bard, Inc. 100 Sockanossett Crossroad, Canston RI
510(k) summary
Summary
Third party review
No

Clearances, product code HRX

Trailing 12 months
9 clearances under product code HRX in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code HRX, trailing twelve months
MonthClearances
November 20252
December 20252
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20262
September 20260
October 20260