Cleared Traditional

K884301 - EDWARDS DISPOSABLE ARTHROSCOPY CANNULA

K884301 is an FDA 510(k) clearance for EDWARDS DISPOSABLE ARTHROSCOPY CANNULA, manufactured by Baxter Healthcare Corp. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 151-day FDA review.

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

FDA 510(k) Submission Details - K884301

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.

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 530
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K884301.
DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE
K894728 · Dyonics, Inc. · Aug 1989
INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)
K892376 · Concept, Inc. · Aug 1989
PS3500 ARTHROSCOPIC SURGICAL SYSTEM
K892062 · Dyonics, Inc. · Jun 1989
BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS
K875130 · Orthopedic Systems, Inc. · Jan 1989
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