Cleared Traditional

K924148 - DIAMOND-SHARP TROCARS

K924148 is the FDA 510(k) clearance for DIAMOND-SHARP TROCARS by Snowden-Pencer. It is a Class 2 Obstetrics & Gynecology device (product code HFI) cleared through the Traditional 510(k) pathway after a 559-day FDA review.

K924148 · Snowden-Pencer · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
559d
Days
Class 2
Risk

K924148 is an FDA 510(k) clearance for the DIAMOND-SHARP(R) TROCARS. Classified as Coagulator, Culdoscopic (and Accessories) (product code HFI), Class II - Special Controls.

Submitted by Snowden-Pencer (Tucker, US). The FDA issued a Cleared decision on February 28, 1994 after a review of 559 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 Snowden-Pencer devices

Submission Details

510(k) Number K924148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1992
Decision Date February 28, 1994
Days to Decision 559 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
399d slower than avg
Panel avg: 160d · This submission: 559d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HFI Coagulator, Culdoscopic (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 - HFI Coagulator, Culdoscopic (and Accessories)

Devices cleared under the same product code (HFI) and FDA review panel - the closest regulatory comparables to K924148.
SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE
K925957 · Zinnanti Surgical Instruments, Inc. · Jun 1994
FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE
K925960 · Zinnanti Surgical Instruments, Inc. · Jun 1994
COOK LAPAROSCOPIC MINI RETRACTOR SET
K936026 · Cook Urological, Inc. · Mar 1994
CANON 60 DEGREE FUNDUS CAMERA CF-60S
K844053 · Canon USA, Inc. · Dec 1984