Cleared Traditional

K911635 - MEADOX SURGIMED BIOPSY GUN II

K911635 is the FDA 510(k) clearance for MEADOX SURGIMED BIOPSY GUN II by Meadox Surgimed, Inc.. It is a Class 2 Gastroenterology & Urology device (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.

View all Meadox Surgimed, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 130d · This submission: 70d
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 165
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K911635.
MANAN PRO-MAG AUTOMATIC BIOPSY DEVICE
K914874 · Manan Medical Products, Inc. · 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
MAXX 470 CORE BIOPSY GUN
K900082 · Dlp, Inc. · Jun 1990
MADAYAG, MANGHINI, FRANSEEN, GREEN, TROCAR NEEDLES
K895457 · Advance Medical Designs, Inc. · Nov 1989
GASTRO ENTEROLOGICAL BIOPTOME
K894419 · Symbiosis Corp. · Sep 1989