Cleared Traditional

K922971 - NO-SCALPEL VASCETOMY INSTRUMENTS

K922971 is an FDA 510(k) clearance for NO-SCALPEL VASCETOMY INSTRUMENTS, manufactured by Pilling Co.. The device is a Class 1 Gastroenterology & Urology device with product code KOA cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K922971 · Pilling Co. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
96d
Days
Class 1
Risk

K922971 is an FDA 510(k) clearance for the NO-SCALPEL VASCETOMY INSTRUMENTS. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by Pilling Co. (Fort Washington, US). The FDA issued a Cleared decision on September 23, 1992 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pilling Co. devices

FDA 510(k) Submission Details - K922971

510(k) Number K922971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1992
Decision Date September 23, 1992
Days to Decision 96 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 131d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

KOA Device Classification - Class 1, General Controls

Product Code KOA Surgical Instruments, G-u, Manual (and Accessories)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KOA Surgical Instruments, G-u, Manual (and Accessories)

All 29
Devices cleared under the same product code (KOA) and FDA review panel - the closest regulatory comparables to K922971.
FiXcision
K182664 · Agency For Medical Innovations GmbH · Dec 2018
URETHRAL SUTURE GUIDE
K950267 · Applied Medical Resources · Jan 1995
VASOVASOSTOMY SET
K921546 · Cook Urological, Inc. · Jul 1993
VAS DILATOR
K922192 · Cook Urological, Inc. · Aug 1992
GRASPING FORCEPS
K896058 · Annex Medical, Inc. · Dec 1989
MICROSURGICAL CYSTOTOME
K890218 · Kinetic Medical Products · Jan 1989