Cleared Traditional

K935086 - AUTO SUTURE DISPOSABLE OPTICAL TROCAR

K935086 is the FDA 510(k) clearance for AUTO SUTURE DISPOSABLE OPTICAL TROCAR 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 118-day FDA review.

K935086 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
118d
Days
Class 2
Risk

K935086 is an FDA 510(k) clearance for the AUTO SUTURE DISPOSABLE OPTICAL TROCAR. 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 February 17, 1994 after a review of 118 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

Submission Details

510(k) Number K935086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1993
Decision Date February 17, 1994
Days to Decision 118 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
3d slower than avg
Panel avg: 115d · This submission: 118d
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 K935086.
STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
K934094 · Stryker Corp. · Feb 1994
5,6,7,9,10,11&12MM BLUNT-TIPPED TROCAR OBTURATORS
K934511 · Phx Technologies Corp. · Feb 1994
YANKAUER WITH CONNECTING TUBING
K934750 · Trinity Laboratories, Inc. · Feb 1994
STERILE TROCAR AND 5.7MM SLEEVE
K940259 · Phx Technologies Corp. · Feb 1994
INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION
K934338 · Innovasive Devices, Inc. · Feb 1994
I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA
K934097 · Sharplan Lasers, Inc. · Feb 1994