Cleared Traditional

K151095 - Circumplast Circumcision Device

K151095 is an FDA 510(k) clearance for Circumplast Circumcision Device, manufactured by Novadien Healthcare. The device is a Class 2 Obstetrics & Gynecology device with product code HFX cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K151095 · Novadien Healthcare · Obstetrics & Gynecology device
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Sep 2015
Decision
148d
Days
Class 2
Risk

K151095 is an FDA 510(k) clearance for the Circumplast Circumcision Device. Classified as Clamp, Circumcision (product code HFX), Class II - Special Controls.

Submitted by Novadien Healthcare (Mount Lewis, AU). The FDA issued a Cleared decision on September 18, 2015 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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.

View all Novadien Healthcare devices

FDA 510(k) Submission Details - K151095

510(k) Number K151095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2015
Decision Date September 18, 2015
Days to Decision 148 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
12d faster than avg
Panel avg: 160d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFX Device Classification - Class 2, Special Controls

Product Code HFX Clamp, Circumcision
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - HFX Clamp, Circumcision

All 9
Devices cleared under the same product code (HFX) and FDA review panel - the closest regulatory comparables to K151095.
Konig Bell Circumcision Clamp
K251687 · Medline Industries, LP · Feb 2026
Wee Bell
K221356 · Wee Medical · Feb 2023
Konig Mogen Clamp
K212911 · Medline Industries, Inc. · Nov 2022
CIRCUMCISION TRAY, CAT. NO. 70340
K974286 · Trinity Laboratories, Inc. · Dec 1997
CIRCUMCISION TRAY
K935697 · Cush Medical Products · May 1994
MOGAN CIRCUMCISION CLAMP
K926471 · Thomasville Medical Assoc. · Feb 1994