Cleared Traditional

K954652 - AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS

K954652 is an FDA 510(k) clearance for AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS, manufactured by Aesculap, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K954652 · Aesculap, Inc. · Orthopedic device
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Feb 1996
Decision
127d
Days
Class 2
Risk

K954652 is an FDA 510(k) clearance for the AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on February 14, 1996 after a review of 127 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 Aesculap, Inc. devices

FDA 510(k) Submission Details - K954652

510(k) Number K954652 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 10, 1995
Decision Date February 14, 1996
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
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 547
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K954652.
ARTHOSCOPE
K960805 · United States Surgical, A Division of Tyco Healthc · Apr 1996
SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE
K960046 · Surgical Dynamics, Inc. · Apr 1996
PERCUTANEOUS ENDOSCOPIC DISCECTOMY
K960222 · Richard Wolf Medical Instruments Corp. · Mar 1996
BOZOTTA REINSERTION FORCEPS
K955480 · KARL STORZ Endoscopy-America, Inc. · Feb 1996
LIMITED REUSE ARTHROSCOPIC BLADES
K955914 · Smith & Nephew Dyonics, Inc. · Feb 1996
FMS ARTHOPROBE
K955500 · Future Medical Systems, Inc. · Feb 1996