Cleared Traditional

K962702 - SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA

K962702 is an FDA 510(k) clearance for SPACEMAKER SERIAL SURGICAL BALLOON DISS..., manufactured by General Surgical Innovations. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K962702 · General Surgical Innovations · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
222d
Days
Class 2
Risk

K962702 is an FDA 510(k) clearance for the SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATIO.... Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by General Surgical Innovations (Palo Alto, US). The FDA issued a Cleared decision on February 19, 1997 after a review of 222 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 General Surgical Innovations devices

FDA 510(k) Submission Details - K962702

510(k) Number K962702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1996
Decision Date February 19, 1997
Days to Decision 222 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
107d slower than avg
Panel avg: 115d · This submission: 222d
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 914
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K962702.
VISTA MINI CAMERA SYSTEM
K970369 · Oktas · Apr 1997
AESOP SYSTEM AND ACCESSORIES
K963126 · Computer Motion, Inc. · Apr 1997
STRYKER SAPHENOUS VEIN HARVEST SCOPE
K964930 · Stryker Endoscopy · Feb 1997
VASOVIEW BALLOON DISSECTION SYSTEM
K964171 · Origin Medsystems, Inc. · Feb 1997
TROCAR CANNULA
K963115 · United States Surgical, A Division of Tyco Healthc · Feb 1997
TANDEMRX
K970054 · Boston Scientific Corp · Feb 1997