Cleared Traditional

K954853 - AUTO SUTURE SUTURE CLOSURE

K954853 is an FDA 510(k) clearance for AUTO SUTURE SUTURE CLOSURE, 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 58-day FDA review.

K954853 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
58d
Days
Class 2
Risk

K954853 is an FDA 510(k) clearance for the AUTO SUTURE SUTURE CLOSURE. 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 December 20, 1995 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all United States Surgical, A Division of Tyco Healthc devices

FDA 510(k) Submission Details - K954853

510(k) Number K954853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1995
Decision Date December 20, 1995
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
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 K954853.
THE TULIP LAPAROSCOPE SHEATH 6MM DUAL STOPCOCK
K952959 · The Tulip Mfg. Co. · Jan 1996
LAPAROSCOPIC KNITTER
K955490 · Core Dynamics, Inc. · Jan 1996
3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY
K943307 · Olympus America, Inc. · Dec 1995
THE TULIP COMPANY BRANSON #1 & #2 ELEVATOR
K952901 · The Tulip Mfg. Co. · Nov 1995
THE TULIP COMPANY BRANSON POSTERIOR DISSECTOR
K952902 · The Tulip Mfg. Co. · Nov 1995
THE TULIP COMPANY BRANSON #1 ELEVATOR
K952932 · The Tulip Mfg. Co. · Nov 1995