Cleared Traditional

K922396 - FUJINON FORCEPS -- MODIFICATION

K922396 is the FDA 510(k) clearance for FUJINON FORCEPS -- MODIFICATION by Hobbs Medical, Inc.. It is a Class 1 Gastroenterology & Urology device (product code FCL) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K922396 · Hobbs Medical, Inc. · Gastroenterology & Urology device
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Dec 1992
Decision
205d
Days
Class 1
Risk

K922396 is an FDA 510(k) clearance for the FUJINON FORCEPS -- MODIFICATION. Classified as Forceps, Biopsy, Non-electric (product code FCL), Class I - General Controls.

Submitted by Hobbs Medical, Inc. (Stafford Springs, US). The FDA issued a Cleared decision on December 10, 1992 after a review of 205 days - an extended review 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: 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 Hobbs Medical, Inc. devices

Submission Details

510(k) Number K922396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1992
Decision Date December 10, 1992
Days to Decision 205 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 130d · This submission: 205d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FCL Forceps, Biopsy, Non-electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1075
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 - FCL Forceps, Biopsy, Non-electric

All 12
Devices cleared under the same product code (FCL) and FDA review panel - the closest regulatory comparables to K922396.
SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS
K931957 · Symbiosis Corp. · Feb 1994
GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS
K935070 · KARL STORZ Endoscopy-America, Inc. · Jan 1994
SYMBIOSIS DISPOS PULMON BIOPSY FORCEPS W/REUS HAND
K932265 · Symbiosis Corp. · Aug 1993
BARD SINGULAR BIOPSY FORCEPS
K914212 · C.R. Bard, Inc. · Nov 1991
BARD(R) DISPOSABLE BIOPSY FORCEPS
K912549 · C.R. Bard, Inc. · Sep 1991
BARD SINGULAR BIOPSY FORCEPS
K912214 · C.R. Bard, Inc. · May 1991