Cleared Traditional

K942415 - R-BAR RETRACTOR

K942415 is the FDA 510(k) clearance for R-BAR RETRACTOR by Linvatec Corp.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K942415 · Linvatec Corp. · General & Plastic Surgery device
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Jun 1994
Decision
24d
Days
Class 2
Risk

K942415 is an FDA 510(k) clearance for the R-BAR RETRACTOR. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on June 13, 1994 after a review of 24 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 Linvatec Corp. devices

Submission Details

510(k) Number K942415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1994
Decision Date June 13, 1994
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
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 677
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K942415.
PSB PREPERITONEAL STRUCTURE BALLOON
K942636 · Origin Medsystems, Inc. · Jul 1994
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K930224 · Stryker Corp. · Jun 1994
TROCAR SLEEVE, SEALING CAPS, REDUCER, LOOP GUIDE
K942414 · Linvatec Corp. · Jun 1994
AESCULAP INTERCHANGEABLE TROCAR INSTRUMENT SET
K942053 · Aesculap, Inc. · Jun 1994
DISPOSABLE ASPIRATION/IRRIGATION TRUMPET VALVE PROBE
K941390 · Deroyal Industries, Inc. · Jun 1994
CABOT MEDICAL SURGIFLEX(R) SUCTION-IRRIGATION PROB
K932626 · Cabot Medical Corp. · Jun 1994