Cleared Traditional

K952630 - DISPOSABLE BIOPSY FORCEP

K952630 is an FDA 510(k) clearance for DISPOSABLE BIOPSY FORCEP, manufactured by Neuro Navigational Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K952630 · Neuro Navigational Corp. · Orthopedic device
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Sep 1995
Decision
92d
Days
Class 2
Risk

K952630 is an FDA 510(k) clearance for the DISPOSABLE BIOPSY FORCEP. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Neuro Navigational Corp. (Costa Mesa, US). The FDA issued a Cleared decision on September 8, 1995 after a review of 92 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 Neuro Navigational Corp. devices

FDA 510(k) Submission Details - K952630

510(k) Number K952630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1995
Decision Date September 08, 1995
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 414
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K952630.
GRASPING FORCEPS, BIOPSY FORCEPS, SCISSORS, PUNCH
K953868 · Richard Wolf Medical Instruments Corp. · Sep 1995
DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY
K930191 · Sofamor Danek Mfg., Inc. · Sep 1995
PRESSURE SENSING SCOPE SHEATH SYSTEM
K944553 · Linvatec Corp. · Sep 1995
DISPOSABLE TOOTHED GRASPING FORCEP
K952639 · Neuro Navigational Corp. · Sep 1995
MICRO-ARTHROSCOPE
K930084 · Medical Devices, Inc. · Sep 1995
STRYKER PRESSURE SENSING CANNULA
K944593 · Stryker Endoscopy · Sep 1995