Cleared Traditional

K942081 - ENVISION ARTHROSCOPY SYSTEM

K942081 is an FDA 510(k) clearance for ENVISION ARTHROSCOPY SYSTEM, manufactured by Envision Surgical System, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K942081 · Envision Surgical System, Inc. · Orthopedic device
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Nov 1994
Decision
194d
Days
Class 2
Risk

K942081 is an FDA 510(k) clearance for the ENVISION ARTHROSCOPY SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Envision Surgical System, Inc. (Palo Alto, US). The FDA issued a Cleared decision on November 9, 1994 after a review of 194 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.

View all Envision Surgical System, Inc. devices

FDA 510(k) Submission Details - K942081

510(k) Number K942081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1994
Decision Date November 09, 1994
Days to Decision 194 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 122d · This submission: 194d
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 577
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K942081.
MENISCAL SUTURE INSTRUMENTARIUM
K940287 · Richard Wolf Medical Instruments Corp. · Nov 1994
DANEKSCOPE OPTI-PROBE
K943676 · Danek Medical, Inc. · Nov 1994
SE5 ARTHROSCOPY SYTEM
K941333 · Stryker Endoscopy · Nov 1994
LIMITED REUSE BLADES
K943985 · Linvatec Corp. · Nov 1994
3M FLUID IRRIGATION SYSTEM
K941388 · 3M Healthcare · Oct 1994
4-LEAD IRRIGATION SET
K942101 · Douglas Medical Products Corp. · Sep 1994