Cleared Traditional

K823295 - MEDIGROUP 2.2MM NEEDLESCOPE CANNULA&

K823295 is the FDA 510(k) clearance for MEDIGROUP 2.2MM NEEDLESCOPE CANNULA& by Medigroup. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K823295 · Medigroup · Obstetrics & Gynecology device
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May 1983
Decision
182d
Days
Class 2
Risk

K823295 is an FDA 510(k) clearance for the MEDIGROUP 2.2MM NEEDLESCOPE CANNULA&. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Medigroup (Mchenry, US). The FDA issued a Cleared decision on May 6, 1983 after a review of 182 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K823295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1982
Decision Date May 06, 1983
Days to Decision 182 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 160d · This submission: 182d
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)

All 154
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KEYMED KEY LIGHT
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K770378 · Richard Wolf Medical Instruments Corp. · Mar 1977