Cleared Traditional

K931898 - ENDOSWAB

K931898 is the FDA 510(k) clearance for ENDOSWAB 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 100-day FDA review.

K931898 · Medline Industries, Inc. · General & Plastic Surgery device
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Jul 1993
Decision
100d
Days
Class 2
Risk

K931898 is an FDA 510(k) clearance for the ENDOSWAB. 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 July 28, 1993 after a review of 100 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K931898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1993
Decision Date July 28, 1993
Days to Decision 100 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
15d faster than avg
Panel avg: 115d · This submission: 100d
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 K931898.
CABOT MEDICAL OPTIMA HAND INSTRUMENTS
K932977 · Cabot Medical Corp. · Sep 1993
SURGICAL TROCAR AND TROCAR SLEEVE
K932229 · Origin Medsystems, Inc. · Aug 1993
LAPAROSCOPIC BALLOON RETRACTOR
K931649 · Cabot Medical Corp. · Aug 1993
MICRO ENDOSCOPIC ELECTRODE (ME2)
K931281 · Codman & Shurtleff, Inc. · Jul 1993
ORIGIN BLUNT TIP SURGICAL TROCAR
K924011 · Origin Medsystems, Inc. · Jul 1993
TROCAR SHEATH ANCHOR
K930301 · Origin Medsystems, Inc. · Jul 1993