Cleared Traditional

K926341 - UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT

K926341 is an FDA 510(k) clearance for UNITROCAR(TM) REUSABLE SURG TROCAR/RESU..., manufactured by Unisurge, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K926341 · Unisurge, Inc. · General & Plastic Surgery device
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May 1993
Decision
151d
Days
Class 2
Risk

K926341 is an FDA 510(k) clearance for the UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Unisurge, Inc. (Cupertino, US). The FDA issued a Cleared decision on May 17, 1993 after a review of 151 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 Unisurge, Inc. devices

FDA 510(k) Submission Details - K926341

510(k) Number K926341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1992
Decision Date May 17, 1993
Days to Decision 151 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
36d slower than avg
Panel avg: 115d · This submission: 151d
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 1096
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K926341.
WIRE GUIDED OVAL DILATORS
K930465 · Surgical Technologies, Inc. · May 1993
COMPRESSION CLAMP
K930466 · Surgical Technologies, Inc. · May 1993
BABCOCK FORCEPS, GRASPING FORCEPS, NEEDLE HOLDER
K930467 · Surgical Technologies, Inc. · May 1993
PRE-TIED LOOP SUTURE CANNULA
K925914 · Ethicon, Inc. · May 1993
GUIDE WIRE FOR LAPOROSCOPIC USE
K926214 · Terumo Medical Corp. · Apr 1993
AUTO SUTURE DILATING CANNULA
K931337 · United States Surgical, A Division of Tyco Healthc · Apr 1993