Cleared Traditional

K960655 - AESOP SYSTEM AND ACCESSORIES

K960655 is an FDA 510(k) clearance for AESOP SYSTEM AND ACCESSORIES, manufactured by Computer Motion, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K960655 · Computer Motion, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
78d
Days
Class 2
Risk

K960655 is an FDA 510(k) clearance for the AESOP SYSTEM AND ACCESSORIES. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Computer Motion, Inc. (Goleta, US). The FDA issued a Cleared decision on May 3, 1996 after a review of 78 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 Computer Motion, Inc. devices

FDA 510(k) Submission Details - K960655

510(k) Number K960655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1996
Decision Date May 03, 1996
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
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 799
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K960655.
5MM ENDOSCOPE
K960637 · Origin Medsystems, Inc. · Jun 1996
HYDRO-FLEX LI LAPAROSCOPIC IRRIGATION SYSTEM
K961224 · Davol Inc., Sub. C. R. Bard, Inc. · May 1996
HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010
K961492 · Davol Inc., Sub. C. R. Bard, Inc. · May 1996
GLEESON FLO VAC & SELECTONE S/I CANNULAE MODEL 60-6001, 6002, 6005
K960562 · Conmedcorp · Apr 1996
MODIFIED HAND INSTRUMENT DEVICES
K960748 · United States Surgical, A Division of Tyco Healthc · Apr 1996
TROGARD TROCAR DIALATING TROCAR SYSTEM
K961175 · Conmedcorp · Apr 1996