Cleared Traditional

K926110 - ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT

K926110 is an FDA 510(k) clearance for ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT, manufactured by Advanced Surgical Intervention, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K926110 · Advanced Surgical Intervention, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
217d
Days
Class 2
Risk

K926110 is an FDA 510(k) clearance for the ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Advanced Surgical Intervention, Inc. (San Clemente, US). The FDA issued a Cleared decision on July 8, 1993 after a review of 217 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 Advanced Surgical Intervention, Inc. devices

FDA 510(k) Submission Details - K926110

510(k) Number K926110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1992
Decision Date July 08, 1993
Days to Decision 217 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
102d slower than avg
Panel avg: 115d · This submission: 217d
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 K926110.
ORIGIN BLUNT TIP SURGICAL TROCAR
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TROCAR SHEATH ANCHOR
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DAVIS+GECK ABSORBABLE LIGATING DEVICE
K925602 · Davis & Geck, Inc. · Jul 1993
ENDOPATH ENDOSCOPIC TISSUE RETRACTOR
K924916 · Ethicon Endo-Surgery, Inc. · Jun 1993
ORC 10.0MM SUCTION PROBE
K925147 · O.R. Concepts, Inc. · Jun 1993
FUJINON VIDEO LAPAROSCOPE, MODIFICATION
K926444 · Fujinon, Inc. · Jun 1993