Cleared Traditional

K944553 - PRESSURE SENSING SCOPE SHEATH SYSTEM

K944553 is the FDA 510(k) clearance for PRESSURE SENSING SCOPE SHEATH SYSTEM by Linvatec Corp.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K944553 · Linvatec Corp. · Orthopedic device
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Sep 1995
Decision
357d
Days
Class 2
Risk

K944553 is an FDA 510(k) clearance for the PRESSURE SENSING SCOPE SHEATH SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on September 8, 1995 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Linvatec Corp. devices

Submission Details

510(k) Number K944553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1994
Decision Date September 08, 1995
Days to Decision 357 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
235d slower than avg
Panel avg: 122d · This submission: 357d
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 361
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K944553.
PROBE
K954476 · Phx Technologies Corp. · Oct 1995
ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODIFICATION)
K953659 · Arthrocare Corp. · Sep 1995
GRASPING FORCEPS, BIOPSY FORCEPS, SCISSORS, PUNCH
K953868 · Richard Wolf Medical Instruments Corp. · Sep 1995
MICRO-ARTHROSCOPE
K930084 · Medical Devices, Inc. · Sep 1995
STRYKER PRESSURE SENSING CANNULA
K944593 · Stryker Endoscopy · Sep 1995
STRYKER UNIVERSAL ACL INSTRUMENTATION SYSTEM
K951267 · Stryker Endoscopy · Sep 1995