Cleared Traditional

K941747 - SURGISTAR TROCARS

K941747 is an FDA 510(k) clearance for SURGISTAR TROCARS, manufactured by Surgistar, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K941747 · Surgistar, Inc. · General & Plastic Surgery device
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Jul 1994
Decision
84d
Days
Class 2
Risk

K941747 is an FDA 510(k) clearance for the SURGISTAR TROCARS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Surgistar, Inc. (Vista, US). The FDA issued a Cleared decision on July 1, 1994 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Surgistar, Inc. devices

FDA 510(k) Submission Details - K941747

510(k) Number K941747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1994
Decision Date July 01, 1994
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

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 1004
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K941747.
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K942678 · Origin Medsystems, Inc. · Jul 1994
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SURGIN IRRIGATION PUMP
K942641 · Surgin Surgical Instrumentation, Inc. · Jul 1994
PSB PREPERITONEAL STRUCTURE BALLOON
K942636 · Origin Medsystems, Inc. · Jul 1994
STRYKER ARTHROSCOPIC ACCESSORIES
K930224 · Stryker Corp. · Jun 1994
TROCAR SLEEVE, SEALING CAPS, REDUCER, LOOP GUIDE
K942414 · Linvatec Corp. · Jun 1994