Cleared Traditional

K935709 - GENERAL SURGERY PROBE/GENERAL SURGERY P...

K935709 is the FDA 510(k) clearance for GENERAL SURGERY PROBE/GENERAL SURGERY P... by Zimmer Patient Care Division. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K935709 · Zimmer Patient Care Division · General & Plastic Surgery device
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Jan 1994
Decision
62d
Days
Class 2
Risk

K935709 is an FDA 510(k) clearance for the GENERAL SURGERY PROBE/GENERAL SURGERY PROBE W/DISTAL PERFORATIONS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Zimmer Patient Care Division (Dover, US). The FDA issued a Cleared decision on January 31, 1994 after a review of 62 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 Zimmer Patient Care Division devices

Submission Details

510(k) Number K935709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1993
Decision Date January 31, 1994
Days to Decision 62 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 115d · This submission: 62d
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 516
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K935709.
LAPAROSCOPIC TROCAR STARTER SCALPEL
K936154 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994
SERIES 8920 TROCAR SYSTEM
K932441 · Richard Wolf Medical Instruments Corp. · Feb 1994
NON-INSULATED SCISSORS
K935073 · KARL STORZ Endoscopy-America, Inc. · Jan 1994
AUTO SUTURE DISPOSABLE ENDOSCOPIC SUTURE NEEDLE
K935762 · United States Surgical, A Division of Tyco Healthc · Jan 1994
PROBES,SCISSORS,FORCEPS,GRASPERS,&NEEDLE HOLDERS
K933067 · Medline Industries, Inc. · Jan 1994
ENDOSCOPIC NEEDLE DRIVER
K933725 · United States Surgical, A Division of Tyco Healthc · Jan 1994