Cleared Traditional

K925149 - AUTO SUTURE ENDOSCOPIC KNOT PUSHER

K925149 is an FDA 510(k) clearance for AUTO SUTURE ENDOSCOPIC KNOT PUSHER, manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K925149 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
105d
Days
Class 2
Risk

K925149 is an FDA 510(k) clearance for the AUTO SUTURE ENDOSCOPIC KNOT PUSHER. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on January 26, 1993 after a review of 105 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 United States Surgical, A Division of Tyco Healthc devices

FDA 510(k) Submission Details - K925149

510(k) Number K925149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1992
Decision Date January 26, 1993
Days to Decision 105 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 115d · This submission: 105d
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 1127
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K925149.
KAISER NO CANNULA THORACOSCOPY/LAPAROSCOPY INSTR
K925198 · Pilling Co. · Feb 1993
GRASPING FORCEPS OR RETRIEVAL FORCEPS
K925267 · Annex Medical, Inc. · Feb 1993
PLEATMAN SAC SPECIMEN CONTAINER
K923945 · Cabot Medical Corp. · Feb 1993
CABOT DISPOSABLE 10MM SUCTION DEVICE
K924048 · Cabot Medical Corp. · Jan 1993
KNOT PUSHER
K924728 · Advanced Surgical, Inc. · Dec 1992
ENDOSCOPE
K921040 · Origin Medsystems, Inc. · Dec 1992