Cleared Traditional

K973698 - SCION BALLOON ELEVATOR

K973698 is an FDA 510(k) clearance for SCION BALLOON ELEVATOR, manufactured by Scion International, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K973698 · Scion International, Inc. · General & Plastic Surgery device
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Mar 1998
Decision
186d
Days
Class 2
Risk

K973698 is an FDA 510(k) clearance for the SCION BALLOON ELEVATOR. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Scion International, Inc. (Miami, US). The FDA issued a Cleared decision on March 31, 1998 after a review of 186 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 Scion International, Inc. devices

FDA 510(k) Submission Details - K973698

510(k) Number K973698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1997
Decision Date March 31, 1998
Days to Decision 186 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
71d slower than avg
Panel avg: 115d · This submission: 186d
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 724
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K973698.
VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM
K981700 · Origin Medsystems, Inc. · May 1998
SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES
K980604 · Smith & Nephew, Inc. · May 1998
COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES
K980079 · Lumenis, Inc. · Apr 1998
ENDOPATH AND PROXIMATE LINEAR CUTTERS
K980023 · Ethicon Endo-Surgery, Inc. · Mar 1998
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
K980022 · Ethicon Endo-Surgery, Inc. · Mar 1998
KSEA ENDOTIP SYSTEM
K973909 · KARL STORZ Endoscopy-America, Inc. · Feb 1998