Cleared Traditional

K910787 - TITANIUM CONNECTOR (2 PART)

K910787 is the FDA 510(k) clearance for TITANIUM CONNECTOR (2 PART) by Accurate Surgical Instruments Co.. It is a Class 2 Gastroenterology & Urology device (product code FKO) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K910787 · Accurate Surgical Instruments Co. · Gastroenterology & Urology device
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Aug 1991
Decision
171d
Days
Class 2
Risk

K910787 is an FDA 510(k) clearance for the TITANIUM CONNECTOR (2 PART). Classified as Catheter, Peritoneal Dialysis, Single Use (product code FKO), Class II - Special Controls.

Submitted by Accurate Surgical Instruments Co. (Toronto Canado M5v 1y9, CA). The FDA issued a Cleared decision on August 15, 1991 after a review of 171 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - 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 Accurate Surgical Instruments Co. devices

Submission Details

510(k) Number K910787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1991
Decision Date August 15, 1991
Days to Decision 171 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
41d slower than avg
Panel avg: 130d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKO Catheter, Peritoneal Dialysis, Single Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 - FKO Catheter, Peritoneal Dialysis, Single Use

All 9
Devices cleared under the same product code (FKO) and FDA review panel - the closest regulatory comparables to K910787.
PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)
K874650 · Quinton, Inc. · Dec 1987
MODIFIED USE OF PULL-APART INTRODUCER SET
K871730 · Quinton, Inc. · May 1987
ACUTE PERITONEAL DIALYSIS KIT
K870472 · Quinton, Inc. · Feb 1987
PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8
K860155 · Medical Components, Inc. · Feb 1986
CAPD STAGED CONNECTOR
K845041 · Abbott Laboratories · Feb 1985
LAZARUS-NELSON PERITONEAL LAVAGE TRAY
K813336 · American Pharmaseal Div. Ahsc · Dec 1981