Cleared Traditional

K925198 - KAISER NO CANNULA THORACOSCOPY/LAPAROSCOPY INSTR

K925198 is an FDA 510(k) clearance for KAISER NO CANNULA THORACOSCOPY/LAPAROSC..., manufactured by Pilling Co.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K925198 · Pilling Co. · General & Plastic Surgery device
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Feb 1993
Decision
119d
Days
Class 2
Risk

K925198 is an FDA 510(k) clearance for the KAISER NO CANNULA THORACOSCOPY/LAPAROSCOPY INSTR. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Pilling Co. (Fort Washington, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 119 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 Pilling Co. devices

FDA 510(k) Submission Details - K925198

510(k) Number K925198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1992
Decision Date February 12, 1993
Days to Decision 119 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 115d · This submission: 119d
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 906
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K925198.
SURGICAL RETRACTOR
K921287 · Advanced Surgical, Inc. · Mar 1993
SYMBIOSIS HEMOSTATIC WAND
K925410 · Symbiosis Corp. · Feb 1993
MAGNETIC RETRIEVER
K925565 · Cook Urological, Inc. · Feb 1993
GRASPING FORCEPS OR RETRIEVAL FORCEPS
K925267 · Annex Medical, Inc. · Feb 1993
PLEATMAN SAC SPECIMEN CONTAINER
K923945 · Cabot Medical Corp. · Feb 1993
AUTO SUTURE ENDOSCOPIC KNOT PUSHER
K925149 · United States Surgical, A Division of Tyco Healthc · Jan 1993