Cleared Traditional

K964879 - PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM

K964879 is an FDA 510(k) clearance for PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR ..., manufactured by Davol Inc., Sub. C. R. Bard, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K964879 · Davol Inc., Sub. C. R. Bard, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
89d
Days
Class 2
Risk

K964879 is an FDA 510(k) clearance for the PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHR.... Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Davol Inc., Sub. C. R. Bard, Inc. (Canston, US). The FDA issued a Cleared decision on March 4, 1997 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Davol Inc., Sub. C. R. Bard, Inc. devices

FDA 510(k) Submission Details - K964879

510(k) Number K964879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1996
Decision Date March 04, 1997
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition 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 At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 567
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K964879.
TENOSCOPE
K970642 · Luxtec Corp. · May 1997
TENOSNARE
K970562 · Luxtec Corp. · May 1997
KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY
K970055 · KARL STORZ Endoscopy-America, Inc. · Mar 1997
COHORT DISCECTOMY SYSTEMS (CDS)
K964975 · Cohort Medical Products Group, Inc. · Feb 1997
EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM
K964919 · Emerald Medical, Inc. · Jan 1997
STRYKER TEMPEST ORTHOPEDIC PUMP
K963304 · Stryker Endoscopy · Jan 1997