Cleared Traditional

K221356 - Wee Bell

K221356 is an FDA 510(k) clearance for Wee Bell, manufactured by Wee Medical. The device is a Class 2 Obstetrics & Gynecology device with product code HFX cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K221356 · Wee Medical · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
268d
Days
Class 2
Risk

K221356 is an FDA 510(k) clearance for the Wee Bell. Classified as Clamp, Circumcision (product code HFX), Class II - Special Controls.

Submitted by Wee Medical (Knoxville, US). The FDA issued a Cleared decision on February 2, 2023 after a review of 268 days - an extended review cycle.

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 Wee Medical devices

FDA 510(k) Submission Details - K221356

510(k) Number K221356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2022
Decision Date February 02, 2023
Days to Decision 268 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
108d slower than avg
Panel avg: 160d · This submission: 268d
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 Consultant

Grace Powers - Powers Regulatory Consulting
Grace Powers

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HFX Clamp, Circumcision

All 8
Devices cleared under the same product code (HFX) and FDA review panel - the closest regulatory comparables to K221356.
Konig Bell Circumcision Clamp
K251687 · Medline Industries, LP · Feb 2026
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
GOMCO CIRCUMCISION CLAMP
K926535 · Thomasville Medical Assoc. · Feb 1994