Cleared Traditional

K962104 - AIRLIFT BALLOON RETRACTON SYSTEM (FDA 510(k) Clearance)

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

K962104 · Origin Medsystems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
104d
Days
Class 2
Risk

K962104 is an FDA 510(k) clearance for the AIRLIFT BALLOON RETRACTON SYSTEM. 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 September 11, 1996 after a review of 104 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 Origin Medsystems, Inc. devices

Submission Details

510(k) Number K962104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1996
Decision Date September 11, 1996
Days to Decision 104 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 114d · This submission: 104d
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 1414
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K962104.
4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)
K252858 · Kms Medical Technology Co., Ltd. · Apr 2026
Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)
K260197 · Suzhou Shenyun Medical Equipment Co., Ltd. · Apr 2026
TL-10 Laparoscopic Scope Cleaner
K260089 · Scopix , Ltd. · Apr 2026
C-Lant Port
K252714 · Vigor Medical Technologies , Ltd. · Feb 2026
Universal Seal (5-12 mm)
K253978 · Intuitive Surgical, Inc. · Feb 2026
1688 4K Camera System with Advanced Imaging Modality
K260185 · Stryker Endoscopy · Feb 2026