Cleared Traditional

K911635 - MEADOX(R) SURGIMED(R) BIOPSY GUN II

K911635 is an FDA 510(k) clearance for MEADOX SURGIMED BIOPSY GUN II, manufactured by Meadox Surgimed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K911635 · Meadox Surgimed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
70d
Days
Class 2
Risk

K911635 is an FDA 510(k) clearance for the MEADOX(R) SURGIMED(R) BIOPSY GUN II. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Meadox Surgimed, Inc. (Oakland, US). The FDA issued a Cleared decision on June 20, 1991 after a review of 70 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K911635

510(k) Number K911635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1991
Decision Date June 20, 1991
Days to Decision 70 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 131d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

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 365
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K911635.
AUTO-VAC BIOPSY NEEDLE
K912892 · Angiomed GmbH & Co. Medizintechnik KG · Feb 1992
APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501
K913098 · Dlp, Inc. · Nov 1991
BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT
K910190 · C.R. Bard, Inc. · Aug 1991
CCC CROWN-CORE-CUT-NEEDLE
K905557 · Uni-Quatro Industries Canada, Inc. · Mar 1991
VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)
K904987 · Vibronics · Feb 1991
AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV
K904658 · Leigh Med Tech, Inc. · Nov 1990
K911635 · MEADOX(R) SURGIMED(R) BIOPSY GUN II
Download PDF Meadox Surgimed, Inc.