Cleared Traditional

K870866 - THE GRIPPER(TM) PORT-A-CATH NEEDLES

K870866 is an FDA 510(k) clearance for THE GRIPPER(TM) PORT-A-CATH NEEDLES, manufactured by Pharmacia, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K870866 · Pharmacia, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
114d
Days
Class 2
Risk

K870866 is an FDA 510(k) clearance for the THE GRIPPER(TM) PORT-A-CATH NEEDLES. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on June 25, 1987 after a review of 114 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Pharmacia, Inc. devices

FDA 510(k) Submission Details - K870866

510(k) Number K870866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date June 25, 1987
Days to Decision 114 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 129d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 772
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K870866.
CHURCHILL ALBUMIN IV ADMINISTRATION SET
K872124 · Churchill Corp. · Oct 1987
CHURCHILL TPN ADMINISTRATION SET
K872123 · Churchill Corp. · Oct 1987
CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE
K872795 · Medex, Inc. · Sep 1987
IV PUMP SET
K871086 · Churchill Corp. · Jun 1987
CHURCHILL-H VENTED IV SET W/METERING CHAMBERS
K871732 · Churchill Corp. · Jun 1987
LIFEPORT(R) 7 INCH CONTINUOUS INFUSION SET
K870581 · Strato Medical Corp. · Apr 1987