Cleared Traditional

K921405 - DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP

K921405 is an FDA 510(k) clearance for DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEA..., manufactured by Davol, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFG cleared through the Traditional 510(k) pathway after a 731-day FDA review.

K921405 · Davol, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
731d
Days
Class 2
Risk

K921405 is an FDA 510(k) clearance for the DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP. Classified as Coagulator, Laparoscopic, Unipolar (and Accessories) (product code HFG), Class II - Special Controls.

Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on March 25, 1994 after a review of 731 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4160 - 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 Davol, Inc. devices

FDA 510(k) Submission Details - K921405

510(k) Number K921405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1992
Decision Date March 25, 1994
Days to Decision 731 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
571d slower than avg
Panel avg: 160d · This submission: 731d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFG Device Classification - Class 2, Special Controls

Product Code HFG Coagulator, Laparoscopic, Unipolar (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4160
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 - HFG Coagulator, Laparoscopic, Unipolar (and Accessories)

All 8
Devices cleared under the same product code (HFG) and FDA review panel - the closest regulatory comparables to K921405.
THE ABLATION SYSTEM
K121858 · Halt Medical, Inc. · Nov 2012
INSULSCAN INSULATION TESTING SYSTEM
K991424 · Medicor Corp. · Jul 1999
ENDO-TECH LTD., TIPS
K961695 · Ratio Design Lab · Jul 1996
DAVOL ELECTROSUGICAL PROBES
K915406 · Davol, Inc. · Feb 1992
AMCATH COAGULATION PROBE
K902555 · Intl. Medical, Inc. · Jun 1990