Cleared Traditional

K921722 - BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA

K921722 is an FDA 510(k) clearance for BARD LEVENTHAL(TM) GYNE-FLO(TM) CANNULA, manufactured by Bard Reproductive Systems. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 753-day FDA review.

K921722 · Bard Reproductive Systems · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
753d
Days
Class 2
Risk

K921722 is an FDA 510(k) clearance for the BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Bard Reproductive Systems (Tewksbury, US). The FDA issued a Cleared decision on May 2, 1994 after a review of 753 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 Bard Reproductive Systems devices

FDA 510(k) Submission Details - K921722

510(k) Number K921722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1992
Decision Date May 02, 1994
Days to Decision 753 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
593d slower than avg
Panel avg: 160d · This submission: 753d
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 K921722.
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K935785 · KARL STORZ Endoscopy-America, Inc. · May 1994
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K940462 · KARL STORZ Endoscopy-America, Inc. · May 1994
KNOT PUSHER, SPOON FORCEPS AND BIOPSY FORCEPS
K940049 · Baxter Healthcare Corp · May 1994
MYOMA DRILL 5MM-8383.611
K940844 · Richard Wolf Medical Instruments Corp. · May 1994
ENDOSCOPE
K925968 · United States Surgical, A Division of Tyco Healthc · Apr 1994
LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT SHEARS
K923259 · Imtec Corp. · Apr 1994