Cleared Traditional

EDWARDS DISPOSABLE ARTHROSCOPY CANNULA (K884301) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K884301 · Baxter Healthcare Corp · Orthopedic device
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Mar 1989
Decision
151d
Days
Class 2
Risk

K884301 is an FDA 510(k) clearance for the EDWARDS DISPOSABLE ARTHROSCOPY CANNULA. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on March 13, 1989 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K884301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1988
Decision Date March 13, 1989
Days to Decision 151 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 122d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 157
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K884301.
MOTOR DRIVEN EXTIRPATION INSTRUMENTS
K904859 · Aesculap, Inc. · Mar 1991
POWERCUT SURGICAL SYSTEM, BLADES, AND ACCESSORIES
K904720 · Baxter Healthcare Corp · Oct 1990
ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (ECTR)
K901617 · Smith & Nephew, Inc. · May 1990
EDWARDS ARTHROSCOPIC LEG HOLDER
K884302 · Baxter Healthcare Corp · Nov 1988
28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES
K881715 · KARL STORZ Endoscopy-America, Inc. · Aug 1988
3M CARPAL TUNNEL
K881703 · 3M Company · Jul 1988