Cleared Traditional

K926021 - NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-...

K926021 is the FDA 510(k) clearance for NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-... by Zinnanti Surgical Instruments, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 493-day FDA review.

K926021 · Zinnanti Surgical Instruments, Inc. · Obstetrics & Gynecology device
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Apr 1994
Decision
493d
Days
Class 2
Risk

K926021 is an FDA 510(k) clearance for the NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on April 7, 1994 after a review of 493 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Zinnanti Surgical Instruments, Inc. devices

Submission Details

510(k) Number K926021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1992
Decision Date April 07, 1994
Days to Decision 493 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
333d slower than avg
Panel avg: 160d · This submission: 493d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

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