Cleared Traditional

K970083 - DYNABITE HOT GI BIOPSY FORCEPS

K970083 is an FDA 510(k) clearance for DYNABITE HOT GI BIOPSY FORCEPS, manufactured by Portlyn Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KGE cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K970083 · Portlyn Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
159d
Days
Class 2
Risk

K970083 is an FDA 510(k) clearance for the DYNABITE HOT GI BIOPSY FORCEPS. Classified as Forceps, Biopsy, Electric (product code KGE), Class II - Special Controls.

Submitted by Portlyn Corp. (Moultonboro, US). The FDA issued a Cleared decision on June 17, 1997 after a review of 159 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 Portlyn Corp. devices

FDA 510(k) Submission Details - K970083

510(k) Number K970083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1997
Decision Date June 17, 1997
Days to Decision 159 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 130d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KGE Device Classification - Class 2, Special Controls

Product Code KGE Forceps, Biopsy, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KGE Forceps, Biopsy, Electric

All 29
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K970083.
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
K000086 · Wilson-Cook Medical, Inc. · Mar 2000
UNIPOLAR OPTICAL BIOPSY FORCEPS
K983811 · Olympus Winter & Ibe GmbH · Dec 1998
RESUABLE HOT BIOPSY FORCEPS
K972505 · United States Endoscopy Group, Inc. · Sep 1997
OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS
K955052 · Olympus America, Inc. · Jan 1996
OLYMPUS FD-5 HOT BIOPSY FORCEPS
K951445 · Olympus America, Inc. · May 1995
KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS
K944765 · KARL STORZ Endoscopy-America, Inc. · Mar 1995