Cleared Traditional

K914922 - UNISURGE TISSUE COLLECTION SYSTEM FOR ENDOS SURG

K914922 is an FDA 510(k) clearance for UNISURGE TISSUE COLLECTION SYSTEM FOR E..., manufactured by Charles L. Rose and Co., Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K914922 · Charles L. Rose and Co., Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 1992
Decision
143d
Days
Class 2
Risk

K914922 is an FDA 510(k) clearance for the UNISURGE TISSUE COLLECTION SYSTEM FOR ENDOS SURG. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Charles L. Rose and Co., Inc. (Mountain View, US). The FDA issued a Cleared decision on March 26, 1992 after a review of 143 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 Charles L. Rose and Co., Inc. devices

FDA 510(k) Submission Details - K914922

510(k) Number K914922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1991
Decision Date March 26, 1992
Days to Decision 143 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
28d slower than avg
Panel avg: 115d · This submission: 143d
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 K914922.
SUCTION/IRRIGATION Y TUBING SET
K922655 · Core Dynamics, Inc. · Jul 1992
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC SCISSORS
K914752 · United States Surgical, A Division of Tyco Healthc · Jun 1992
LAP TISSUE COLLECTION BAG
K915286 · Baxter Healthcare Corp · Apr 1992
LM15(TM), CATALOG NUMBER - 523821
K914690 · Edward Weck, Inc. · Mar 1992
ENDOPATH ENDOS LINEAR CUT W/SAF LOCK-OUT/RELOAD UN
K915099 · Ethicon, Inc. · Mar 1992
ENDOSCOPIC TRANSLUMINATOR
K915854 · O.R. Concepts, Inc. · Mar 1992