Cleared Traditional

K913098 - APIRATION BIOPSY SYRINGE GUN

K913098 is the FDA 510(k) clearance for APIRATION BIOPSY SYRINGE GUN by Dlp, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K913098 · Dlp, Inc. · Gastroenterology & Urology device
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Nov 1991
Decision
116d
Days
Class 2
Risk

K913098 is an FDA 510(k) clearance for the APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on November 5, 1991 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - 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 Dlp, Inc. devices

Submission Details

510(k) Number K913098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1991
Decision Date November 05, 1991
Days to Decision 116 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 130d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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 - KNW Instrument, Biopsy

All 171
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K913098.
BIOPSY FORCEPS
K924106 · United States Endoscopy Group, Inc. · Nov 1992
MEADOX SURGIMED BIOPSY GUN III
K922879 · Meadox Medicals, Div. Boston Scientific Corp. · Sep 1992
MANAN PRO-MAG AUTOMATIC BIOPSY DEVICE
K914874 · Manan Medical Products, Inc. · Feb 1992
BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT
K910190 · C.R. Bard, Inc. · Aug 1991
MAXX 470 CORE BIOPSY GUN
K900082 · Dlp, Inc. · Jun 1990
MADAYAG, MANGHINI, FRANSEEN, GREEN, TROCAR NEEDLES
K895457 · Advance Medical Designs, Inc. · Nov 1989