Cleared Traditional

K921709 - ENDOBAG

K921709 is the FDA 510(k) clearance for ENDOBAG by Dexide, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K921709 · Dexide, Inc. · General & Plastic Surgery device
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Jul 1992
Decision
126d
Days
Class 2
Risk

K921709 is an FDA 510(k) clearance for the ENDOBAG, MODIFICATION. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Dexide, Inc. (Fort Worth, US). The FDA issued a Cleared decision on July 14, 1992 after a review of 126 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 Dexide, Inc. devices

Submission Details

510(k) Number K921709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1992
Decision Date July 14, 1992
Days to Decision 126 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
11d slower than avg
Panel avg: 115d · This submission: 126d
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 693
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K921709.
O.R.C. ADAPTER
K922405 · O.R. Concepts, Inc. · Aug 1992
INSTRUMENT, MANUAL, GENERAL SURGICAL
K922571 · Symbiosis Corp. · Aug 1992
HOOK SURGICAL INSTRUMENT
K920599 · Origin Medsystems, Inc. · Jul 1992
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC SCISSORS
K914752 · United States Surgical, A Division of Tyco Healthc · Jun 1992
LAP TISSUE COLLECTION BAG
K915286 · Baxter Healthcare Corp · Apr 1992
LM15(TM), CATALOG NUMBER - 523821
K914690 · Edward Weck, Inc. · Mar 1992