Cleared Traditional

K970511 - DYONICS DISPOSABLE ENDOSCOPIC SURGERY B...

K970511 is the FDA 510(k) clearance for DYONICS DISPOSABLE ENDOSCOPIC SURGERY B... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K970511 · Smith & Nephew, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 1997
Decision
182d
Days
Class 2
Risk

K970511 is an FDA 510(k) clearance for the DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on August 12, 1997 after a review of 182 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K970511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1997
Decision Date August 12, 1997
Days to Decision 182 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
60d slower than avg
Panel avg: 122d · This submission: 182d
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 K970511.
KSEA ARTHROPUMP PLUS
K971649 · KARL STORZ Endoscopy-America, Inc. · Oct 1997
TOTAL PERFORMANCE SYSTEM SHAVER
K973195 · Stryker Endoscopy · Oct 1997
BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM
K972768 · Blackstone Medical, Inc. · Sep 1997
LIMITED REUSE ENDOSCOPIC BLADES
K971676 · Smith & Nephew, Inc. · Jun 1997
UNIVERSAL DRIVE SYSTEM
K971059 · Linvatec Corp. · Jun 1997
VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS
K971253 · Smith & Nephew, Inc. · Jun 1997