Cleared Traditional

K954014 - PERCUTANEOUS DISCECTOMY CANNULA SYSTEM

K954014 is an FDA 510(k) clearance for PERCUTANEOUS DISCECTOMY CANNULA SYSTEM, manufactured by T. Korossurgical Instruments Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K954014 · T. Korossurgical Instruments Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
73d
Days
Class 2
Risk

K954014 is an FDA 510(k) clearance for the PERCUTANEOUS DISCECTOMY CANNULA SYSTEM. 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 November 6, 1995 after a review of 73 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 T. Korossurgical Instruments Corp. devices

FDA 510(k) Submission Details - K954014

510(k) Number K954014 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 25, 1995
Decision Date November 06, 1995
Days to Decision 73 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
49d faster than avg
Panel avg: 122d · This submission: 73d
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 393
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K954014.
PROBE KNIFE
K954509 · Phx Technologies Corp. · Nov 1995
RRIANGLE KNIFE
K954510 · Phx Technologies Corp. · Nov 1995
ARTHROSCOPE
K942029 · Surgical Technologies, Inc. · Nov 1995
ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES
K954052 · T. Korossurgical Instruments Corp. · Nov 1995
APEX TUBING SET
K954440 · Linvatec Corp. · Nov 1995
BOAT NOSE OBTURATOR
K954458 · Phx Technologies Corp. · Oct 1995