Cleared Traditional

K770595 - SUTURE REMOVAL SET

K770595 is an FDA 510(k) clearance for SUTURE REMOVAL SET, manufactured by Abco Dealers, Inc.. The device is a Class 1 General Hospital device with product code JOK cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K770595 · Abco Dealers, Inc. · General Hospital
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May 1977
Decision
56d
Days
Class 1
Risk

K770595 is an FDA 510(k) clearance for the SUTURE REMOVAL SET. Classified as Scissors, Medical, Disposable (product code JOK), Class I - General Controls.

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 23, 1977 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6820 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K770595

510(k) Number K770595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1977
Decision Date May 23, 1977
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

JOK Device Classification - Class 1, General Controls

Product Code JOK Scissors, Medical, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6820
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 - JOK Scissors, Medical, Disposable

Devices cleared under the same product code (JOK) and FDA review panel - the closest regulatory comparables to K770595.
SUTURE REMOVAL KIT
K855131 · Dynarex Corp. · Jan 1986
UTILITY SCISSORS DISPOSABLE ITEMS
K843075 · Greene International Corp. · Sep 1984
DISPOSABLE SUTURE REMOVAL SCISSORS
K812555 · Medcare Products · Nov 1981
SHEAR, PLASTIC HANDLE UTILITY S-475-7
K770481 · Acme United Corp. · Apr 1977
SUTURE CUTTER
K770163 · Concept, Inc. · Mar 1977
DRESSING CHANGE KIT
K761192 · Superior Plastic Products Corp. · Feb 1977
K770595 · SUTURE REMOVAL SET
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