Cleared Traditional

K926181 - ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY

K926181 is the FDA 510(k) clearance for ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY by Zinnanti Surgical Instruments, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 374-day FDA review.

K926181 · Zinnanti Surgical Instruments, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
374d
Days
Class 2
Risk

K926181 is an FDA 510(k) clearance for the ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on December 17, 1993 after a review of 374 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Zinnanti Surgical Instruments, Inc. devices

Submission Details

510(k) Number K926181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1992
Decision Date December 17, 1993
Days to Decision 374 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
259d slower than avg
Panel avg: 115d · This submission: 374d
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 693
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K926181.
SENSOR-TIP TROCAR
K933724 · Origin Medsystems, Inc. · Dec 1993
WATTS RAKE DEVICE
K934163 · Phx Technologies Corp. · Dec 1993
AESCULAP RIGID ENDOSCOPES
K933834 · Aesculap, Inc. · Dec 1993
PHX TECHNOLOGIES CORP., BOWEL GRASPER DEVICE
K934021 · Phx Technologies Corp. · Dec 1993
PHX TECH SINGLE ACTION HEAVY-TOOTH JAW CLAW GRASPER
K934022 · Phx Technologies Corp. · Dec 1993
PHX TECHNOLOGIES CORP., ALTRAUMATIC GRASPER DEVICE
K934023 · Phx Technologies Corp. · Dec 1993