Cleared Traditional

K841003 - PROBES, VARIOUS

K841003 is an FDA 510(k) clearance for PROBES, manufactured by Premier Dental Products Co.. The device is a Class 1 Gastroenterology & Urology device with product code KOA cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K841003 · Premier Dental Products Co. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
11d
Days
Class 1
Risk

K841003 is an FDA 510(k) clearance for the PROBES, VARIOUS. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by Premier Dental Products Co. (Norristown, US). The FDA issued a Cleared decision on March 20, 1984 after a review of 11 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Premier Dental Products Co. devices

FDA 510(k) Submission Details - K841003

510(k) Number K841003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1984
Decision Date March 20, 1984
Days to Decision 11 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 130d · This submission: 11d
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 K841003.
OP-CON SURG. INSTRUMENT #3
K834171 · Imm Enterprises , Ltd. · Apr 1984
JAKOBI SURGICAL INSTRUMENTS #3 17/18/19
K834191 · Imm Enterprises , Ltd. · Mar 1984
JAKOBI SURG. INSTRUMENTS #3 21/22/24
K834192 · Imm Enterprises , Ltd. · Mar 1984
P-S MEDICAL BERLIN VISADUCT KIT
K832677 · Pudenz-Schulte Medical Research Corp. · Dec 1983
DISIMETRIC RELEASE OF INSTRANETICS RAD
K830786 · American Convertors Div., American Pharmaseal · May 1983
ST. MARK'S RECTAL BIOPSY FORCEPS
K822401 · Keymed, Inc. · Aug 1982