Cleared Traditional

K904723 - FORCEPS

K904723 is an FDA 510(k) clearance for FORCEPS, manufactured by Minto Research & Development, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEN cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K904723 · Minto Research & Development, Inc. · General & Plastic Surgery device
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Jul 1991
Decision
282d
Days
Class 1
Risk

K904723 is an FDA 510(k) clearance for the FORCEPS. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Minto Research & Development, Inc. (Redding, US). The FDA issued a Cleared decision on July 26, 1991 after a review of 282 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Minto Research & Development, Inc. devices

FDA 510(k) Submission Details - K904723

510(k) Number K904723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1990
Decision Date July 26, 1991
Days to Decision 282 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 115d · This submission: 282d
Pathway characteristics
Predicate-based equivalence.

GEN Device Classification - Class 1, General Controls

Product Code GEN Forceps, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GEN Forceps, General & Plastic Surgery

All 69
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K904723.
PALPATION PROBE
K911159 · Northgate Technologies, Inc. · Mar 1991
GS-1002 GRASPING FORCEP, 5MM WITH RATCHET
K900948 · Solos Endoscopy, Inc. · Apr 1990
GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP
K900951 · Solos Endoscopy, Inc. · Apr 1990
GS-1200 GRASPING/EXTRACTING FORCEP, 10MM
K900952 · Solos Endoscopy, Inc. · Apr 1990
GS-1500 CLAW FORCEP, 10MM
K900960 · Solos Endoscopy, Inc. · Apr 1990
TISSUE FORCEPS, VARIOUS TYPES
K891896 · Zinnanti Surgical Instruments, Inc. · Apr 1989