Cleared Traditional

K944245 - DYNABITE LAPAROSCOPIC FORCEPS

K944245 is an FDA 510(k) clearance for DYNABITE LAPAROSCOPIC FORCEPS, manufactured by Portlyn Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K944245 · Portlyn Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
77d
Days
Class 2
Risk

K944245 is an FDA 510(k) clearance for the DYNABITE LAPAROSCOPIC FORCEPS. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Portlyn Corp. (Moultonboro, US). The FDA issued a Cleared decision on November 15, 1994 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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: 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 Portlyn Corp. devices

FDA 510(k) Submission Details - K944245

510(k) Number K944245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1994
Decision Date November 15, 1994
Days to Decision 77 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
83d faster than avg
Panel avg: 160d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 - HET Laparoscope, Gynecologic (and Accessories)

All 166
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K944245.
HASSON OPEN LAPAROSCOPY CANNULA
K942447 · Linvatec Corp. · Dec 1994
LAPAROVIEW
K931065 · Northgate Technologies, Inc. · Nov 1994
INSUFFLATOR TUBING WITH FILTER
K943508 · Stryker Endoscopy · Nov 1994
ZEISS OPMI L STEREO-LAPAROSCOPE
K931478 · Carl Zeiss, Inc. · Sep 1994
IRRIGATION PUMP AND TUBING SET
K924611 · Marlo Surgical Technology · Jun 1994
ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL)
K940505 · Uresil Corp. · Jun 1994