Cleared Traditional

K981156 - DYONICS INTELIJET INFLOW/OUTFLOW CANNULA

K981156 is the FDA 510(k) clearance for DYONICS INTELIJET INFLOW/OUTFLOW CANNULA by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K981156 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
50d
Days
Class 2
Risk

K981156 is an FDA 510(k) clearance for the DYONICS INTELIJET INFLOW/OUTFLOW CANNULA. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on May 20, 1998 after a review of 50 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K981156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1998
Decision Date May 20, 1998
Days to Decision 50 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
72d faster than avg
Panel avg: 122d · This submission: 50d
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 376
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K981156.
STRYKER HIP ARTHOROSCOPY SET
K982375 · Stryker Endoscopy · Oct 1998
INTEGRATED DRIVE/PUMP SYSTEM
K981636 · Linvatec Corp. · Aug 1998
UNIVERSAL DRIVE SYSTEM
K981269 · Linvatec Corp. · Jun 1998
YEUNG ENDOSCOPIC SPINE SYSTEM
K973405 · Richard Wolf Medical Instruments Corp. · Mar 1998
XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM
K973499 · Xomed, Inc. · Jan 1998
KSEA ARTHROPUMP PLUS
K971649 · KARL STORZ Endoscopy-America, Inc. · Oct 1997