Cleared Traditional

K953418 - ELECTROCAUTERY SHROUD

K953418 is an FDA 510(k) clearance for ELECTROCAUTERY SHROUD, manufactured by I.C Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K953418 · I.C Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
85d
Days
Class 2
Risk

K953418 is an FDA 510(k) clearance for the ELECTROCAUTERY SHROUD. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by I.C Medical, Inc. (Glendale, US). The FDA issued a Cleared decision on October 7, 1995 after a review of 85 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 I.C Medical, Inc. devices

FDA 510(k) Submission Details - K953418

510(k) Number K953418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1995
Decision Date October 07, 1995
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
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 907
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K953418.
LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM
K953903 · Core Dynamics, Inc. · Oct 1995
MODIFIED VERSAPORT
K954108 · United States Surgical, A Division of Tyco Healthc · Oct 1995
LAPAROSCOPIC TROCAR
K953409 · Core Dynamics, Inc. · Oct 1995
THE TULIP SMALL SOFT TISSUE RETRACTOR
K952935 · The Tulip Mfg. Co. · Sep 1995
THE TULIP LARGE SOFT TISSUE RETRACTOR
K952980 · The Tulip Mfg. Co. · Sep 1995
THE TULIP J DISSECTOR
K952965 · The Tulip Mfg. Co. · Sep 1995