Cleared Traditional

K933067 - PROBES

K933067 is the FDA 510(k) clearance for PROBES by Medline Industries, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K933067 · Medline Industries, Inc. · General & Plastic Surgery device
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Jan 1994
Decision
219d
Days
Class 2
Risk

K933067 is an FDA 510(k) clearance for the PROBES,SCISSORS,FORCEPS,GRASPERS,&NEEDLE HOLDERS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on January 27, 1994 after a review of 219 days - an extended review 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: 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K933067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1993
Decision Date January 27, 1994
Days to Decision 219 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
104d slower than avg
Panel avg: 115d · This submission: 219d
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 677
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K933067.
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
HYDRO-PROBE
K934157 · Phx Technologies Corp. · Jan 1994
5MM CALIBRATED SUCTION CANNULA
K934158 · Phx Technologies Corp. · Jan 1994
PREPERITONEAL DISTENTION BALLOON SYSTEM
K935426 · Origin Medsystems, Inc. · Jan 1994