Cleared Traditional

ENDOFLUSH SYSTEM 1.0, 2.O, 3.0 (K935207) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K935207 · Specialty Medical Systems, Inc. · General & Plastic Surgery device
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Apr 1994
Decision
174d
Days
Class 2
Risk

K935207 is an FDA 510(k) clearance for the ENDOFLUSH SYSTEM 1.0, 2.O, 3.0. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Specialty Medical Systems, Inc. (Fort Worth, US). The FDA issued a Cleared decision on April 21, 1994 after a review of 174 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 Specialty Medical Systems, Inc. devices

Submission Details

510(k) Number K935207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1993
Decision Date April 21, 1994
Days to Decision 174 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 115d · This submission: 174d
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 399
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K935207.
GORE LAPAROSCOPIC SUTURE PASSER
K935986 · W.L. Gore & Associates, Inc. · May 1994
SCISSORS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES
K940346 · KARL STORZ Endoscopy-America, Inc. · May 1994
INSULATED FORCEPS, BIOPSY FORCEPS, SCISSORS
K935071 · KARL STORZ Endoscopy-America, Inc. · Apr 1994
APPENDIX EXTRACTOR 8385.50
K940900 · Richard Wolf Medical Instruments Corp. · Apr 1994
AESCULAP TROCAR COLLAR
K941024 · Aesculap, Inc. · Apr 1994
MURDOCH LAPAROSCOPE LENS CLEANER
K941092 · Cook, Inc. · Apr 1994