Cleared Traditional

DISCETOME TISSUE ASPIRATOR (K953998) - FDA 510(k) Clearance

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

K953998 · T. Korossurgical Instruments Corp. · Orthopedic device
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Dec 1995
Decision
102d
Days
Class 2
Risk

K953998 is an FDA 510(k) clearance for the DISCETOME TISSUE ASPIRATOR. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on December 4, 1995 after a review of 102 days - within the typical 510(k) review window.

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 T. Korossurgical Instruments Corp. devices

Submission Details

510(k) Number K953998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1995
Decision Date December 04, 1995
Days to Decision 102 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 122d · This submission: 102d
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 178
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K953998.
AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS
K954652 · Aesculap, Inc. · Feb 1996
BOZOTTA REINSERTION FORCEPS
K955480 · KARL STORZ Endoscopy-America, Inc. · Feb 1996
KARL STORZ TARGETING UNIT
K955652 · KARL STORZ Endoscopy-America, Inc. · Jan 1996
KARL STORZ HEMPFLING DILATION SET
K954981 · KARL STORZ Endoscopy-America, Inc. · Dec 1995
TAKE-APART ARTHRO-SCISSORS, GASPING, BIOPSY PUNCH FORCEPS FOR ARTHROSCOPY
K955272 · KARL STORZ Endoscopy-America, Inc. · Dec 1995
GRASPING FORCEPS, BIOPSY FORCEPS, SCISSORS, PUNCH
K953868 · Richard Wolf Medical Instruments Corp. · Sep 1995