Cleared Traditional

K954175 - DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM...

K954175 is an FDA 510(k) clearance for DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM..., manufactured by Origin Medsystems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K954175 · Origin Medsystems, Inc. · General & Plastic Surgery device
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Nov 1995
Decision
65d
Days
Class 2
Risk

K954175 is an FDA 510(k) clearance for the DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM SIZES]. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Origin Medsystems, Inc. (Menlo Park, US). The FDA issued a Cleared decision on November 9, 1995 after a review of 65 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 Origin Medsystems, Inc. devices

FDA 510(k) Submission Details - K954175

510(k) Number K954175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1995
Decision Date November 09, 1995
Days to Decision 65 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
50d faster than avg
Panel avg: 115d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

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 723
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K954175.
3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY
K943307 · Olympus America, Inc. · Dec 1995
AUTO SUTURE SUTURE CLOSURE
K954853 · United States Surgical, A Division of Tyco Healthc · Dec 1995
DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES]
K954174 · Origin Medsystems, Inc. · Nov 1995
ENDOPATH OPEN OR ENDOSCOPIC ELECTROSUGICAL COAGULATION & CUTTING DEVICE
K954089 · Ethicon Endo-Surgery, Inc. · Nov 1995
DISTENTION BALLOON
K953377 · Origin Medsystems, Inc. · Oct 1995
MODIFIED VERSAPORT
K954108 · United States Surgical, A Division of Tyco Healthc · Oct 1995