Cleared Traditional

K823581 - ELPHA 500

K823581 is the FDA 510(k) clearance for ELPHA 500 by Prothia USA, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K823581 · Prothia USA, Inc. · General & Plastic Surgery device
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Mar 1983
Decision
108d
Days
Class 2
Risk

K823581 is an FDA 510(k) clearance for the ELPHA 500. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Prothia USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 108 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Prothia USA, Inc. devices

Submission Details

510(k) Number K823581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1982
Decision Date March 24, 1983
Days to Decision 108 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 115d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 522
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K823581.
STRYKER LAPAROSCOPE
K910132 · Stryker Corp. · Feb 1991
STERILE DISPOSABLE TROCAR-SLEEVE DEVICES
K862611 · United States Surgical, A Division of Tyco Healthc · Jul 1986
UNIVERSAL CANNULA
K830719 · Acufex Microsurgical, Inc. · Jun 1983
TROCAR SLEEVE SYSTEM, 6.5MM TO 5.0MM
K770711 · Richard Wolf Medical Instruments Corp. · Apr 1977
TROCAR SLEEVE SYSTEM 4MM TO 3.4MM
K770712 · Richard Wolf Medical Instruments Corp. · Apr 1977
TROCAR SLEEVE SYSTEM, EXTENDED
K770348 · Richard Wolf Medical Instruments Corp. · Mar 1977