Cleared Traditional

K933300 - GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST.

K933300 is an FDA 510(k) clearance for GEISTER SURGICAL INT'L MONOPOLAR ENDOSC..., manufactured by Lyle Howard Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code KNF cleared through the Traditional 510(k) pathway after a 450-day FDA review.

K933300 · Lyle Howard Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
450d
Days
Class 2
Risk

K933300 is an FDA 510(k) clearance for the GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST.. Classified as Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (product code KNF), Class II - Special Controls.

Submitted by Lyle Howard Corp. (Lebanon, US). The FDA issued a Cleared decision on September 30, 1994 after a review of 450 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 Lyle Howard Corp. devices

FDA 510(k) Submission Details - K933300

510(k) Number K933300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1993
Decision Date September 30, 1994
Days to Decision 450 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
290d slower than avg
Panel avg: 160d · This submission: 450d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNF Device Classification - Class 2, Special Controls

Product Code KNF Coagulator-cutter, Endoscopic, 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 - KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories)

All 35
Devices cleared under the same product code (KNF) and FDA review panel - the closest regulatory comparables to K933300.
KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES
K944793 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
KARL STORZ INSULATED SCISSORS
K944297 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
KARL STORZ INSULATED BIOPSY FORCEPS
K944300 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
ENDOMED LAPAROSCOPY INSTRUMENTS
K921686 · Buckman Co., Inc. · Mar 1994
REFLEX(R) ESC
K924200 · Richard-Allan Medical Ind., Inc. · Feb 1994
ELECTRO-GYNE ELECTROSURGICAL GENERATOR
K871960 · Cabot Medical Corp. · Jul 1987