Cleared Traditional

K896058 - GRASPING FORCEPS

K896058 is an FDA 510(k) clearance for GRASPING FORCEPS, manufactured by Annex Medical, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code KOA cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K896058 · Annex Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
71d
Days
Class 1
Risk

K896058 is an FDA 510(k) clearance for the GRASPING FORCEPS. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by Annex Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 28, 1989 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - 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 Annex Medical, Inc. devices

FDA 510(k) Submission Details - K896058

510(k) Number K896058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1989
Decision Date December 28, 1989
Days to Decision 71 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
59d faster than avg
Panel avg: 130d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

KOA Device Classification - Class 1, General Controls

Product Code KOA Surgical Instruments, G-u, Manual (and Accessories)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KOA Surgical Instruments, G-u, Manual (and Accessories)

All 25
Devices cleared under the same product code (KOA) and FDA review panel - the closest regulatory comparables to K896058.
VASOVASOSTOMY SET
K921546 · Cook Urological, Inc. · Jul 1993
NO-SCALPEL VASCETOMY INSTRUMENTS
K922971 · Pilling Co. · Sep 1992
VAS DILATOR
K922192 · Cook Urological, Inc. · Aug 1992
MICROSURGICAL CYSTOTOME
K890218 · Kinetic Medical Products · Jan 1989
STOMACH EVACULATOR - EWALD STYLE
K864963 · Medovations, Inc. · Oct 1987
BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420
K852725 · The Huxley Instrument Corp. · Jul 1985