Cleared Traditional

K925860 - MODIFIED AUTO SUTURE SURGIPORT PREMIUM ...

K925860 is the FDA 510(k) clearance for MODIFIED AUTO SUTURE SURGIPORT PREMIUM ... by United States Surgical, A Division of Tyco Healthc. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K925860 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
155d
Days
Class 2
Risk

K925860 is an FDA 510(k) clearance for the MODIFIED AUTO SUTURE SURGIPORT PREMIUM SEAL. 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 April 23, 1993 after a review of 155 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K925860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1992
Decision Date April 23, 1993
Days to Decision 155 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
40d slower than avg
Panel avg: 115d · This submission: 155d
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 720
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K925860.
AUTO SUTURE DILATING CANNULA
K931337 · United States Surgical, A Division of Tyco Healthc · Apr 1993
ENDOPATH TISSUE EXTRACTION CANNULA
K930935 · Ethicon, Inc. · Apr 1993
LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC.
K922987 · Biosearch Medical Products, Inc. · Apr 1993
MARLOW LAPAROSCOPIC GRASPING FORCEP
K920611 · Marlo Surgical Technology · Apr 1993
STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD
K924761 · Richard-Allan Medical Ind., Inc. · Apr 1993
ENDOPATH II DISPOSABLE SURGICAL TROCAR & SLEEVE
K924035 · Ethicon Endo-Surgery, Inc. · Apr 1993