Cleared Traditional

K771961 - DUAL INCISION TUBAL OCCLUS. BAND APPLI.

K771961 is an FDA 510(k) clearance for DUAL INCISION TUBAL OCCLUS. BAND APPLI., manufactured by Kli. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K771961 · Kli · Obstetrics & Gynecology device
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Oct 1977
Decision
8d
Days
Class 2
Risk

K771961 is an FDA 510(k) clearance for the DUAL INCISION TUBAL OCCLUS. BAND APPLI.. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Kli (Mchenry, US). The FDA issued a Cleared decision on October 25, 1977 after a review of 8 days - a notably fast clearance 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: 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 Kli devices

FDA 510(k) Submission Details - K771961

510(k) Number K771961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1977
Decision Date October 25, 1977
Days to Decision 8 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
152d faster than avg
Panel avg: 160d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

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 228
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K771961.
12MM SELF-SEALING TROCAR & CANNULA
K771958 · Kli · Oct 1977
8MM SELF-SEALING TROCAR & CANNULA
K771959 · Kli · Oct 1977
TUBAL OCCLUSION INSERTER/LAPAROSCOPE
K771960 · Kli · Oct 1977
SINGLE INCISION TUBAL OCCLU. BAND APPL.
K771963 · Kli · Oct 1977
8MM TROCAR & CANNUAL W/STOPCOCK
K771964 · Kli · Oct 1977
LAPAROSCOPE, FIBER LIGHT, PALMER-JACOBS
K770378 · Richard Wolf Medical Instruments Corp. · Mar 1977