Cleared Traditional

K931928 - JARIT SURGICAL INSTRUMENTS

K931928 is the FDA 510(k) clearance for JARIT SURGICAL INSTRUMENTS by J. Jamner Surgical Instruments, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K931928 · J. Jamner Surgical Instruments, Inc. · General & Plastic Surgery device
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Nov 1993
Decision
208d
Days
Class 2
Risk

K931928 is an FDA 510(k) clearance for the JARIT SURGICAL INSTRUMENTS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by J. Jamner Surgical Instruments, Inc. (Great Neck, US). The FDA issued a Cleared decision on November 10, 1993 after a review of 208 days - an extended review 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: 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 J. Jamner Surgical Instruments, Inc. devices

Submission Details

510(k) Number K931928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1993
Decision Date November 10, 1993
Days to Decision 208 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
93d slower than avg
Panel avg: 115d · This submission: 208d
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 721
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K931928.
FORCEPS FOR LAPAROSCOPIC SURGERY GU USE
K925959 · Zinnanti Surgical Instruments, Inc. · Nov 1993
NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE
K926016 · Zinnanti Surgical Instruments, Inc. · Nov 1993
MICROWAVE INSURG INTRODUCER
K933985 · Boston Scientific Corp · Nov 1993
COMED TROGARD(TM) BLUNT TIP TROCAR/SLEEVE
K933456 · Conmedcorp · Nov 1993
LAPAROSCOPIC BALLOON RETRACTOR
K926480 · Origin Medsystems, Inc. · Oct 1993
ENDOPATH EP DISPOSABLE TROCAR
K922608 · Ethicon, Inc. · Oct 1993