Cleared Traditional

K011202 - MSI BIPOLAR SHEATH

K011202 is an FDA 510(k) clearance for MSI BIPOLAR SHEATH, manufactured by Medical Scientific, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K011202 · Medical Scientific, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
256d
Days
Class 2
Risk

K011202 is an FDA 510(k) clearance for the MSI BIPOLAR SHEATH. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Medical Scientific, Inc. (Taunton, US). The FDA issued a Cleared decision on December 31, 2001 after a review of 256 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.

FDA 510(k) Submission Details - K011202

510(k) Number K011202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2001
Decision Date December 31, 2001
Days to Decision 256 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
134d slower than avg
Panel avg: 122d · This submission: 256d
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 684
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K011202.
ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS
K012640 · Medical Instruments Technology, Inc. · Feb 2002
TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
K020083 · Tuta Healthcare Pty Limited · Feb 2002
DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE
K013513 · Pain Concepts, Inc. · Jan 2002
SPINE SCOPE, MODEL 2180
K011454 · Clarus Medical, LLC · Dec 2001
RESECTION ABLATOR
K013117 · Linvatec Corp. · Nov 2001
REPROCESSED LINVATEC ARTHROSCOPIC BURS
K012630 · Alliance Medical, Inc. · Nov 2001
K011202 · MSI BIPOLAR SHEATH
Download PDF FDA Summary Medical Scientific, I…