Cleared Traditional

K912605 - AMCATH DISPOSABLE MICRO SCISSORS

K912605 is an FDA 510(k) clearance for AMCATH DISPOSABLE MICRO SCISSORS, manufactured by Intl. Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K912605 · Intl. Medical, Inc. · General & Plastic Surgery device
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Jul 1991
Decision
29d
Days
Class 2
Risk

K912605 is an FDA 510(k) clearance for the AMCATH DISPOSABLE MICRO SCISSORS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Intl. Medical, Inc. (Danielson, US). The FDA issued a Cleared decision on July 11, 1991 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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: 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 Intl. Medical, Inc. devices

FDA 510(k) Submission Details - K912605

510(k) Number K912605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1991
Decision Date July 11, 1991
Days to Decision 29 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 905
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K912605.
MONOSCOPY(TM) BRAND, ELECTROSURGICAL RAKE
K913104 · Dexide, Inc. · Jul 1991
MONOSCOPY BRAND 5MM LOCK TROCAR SLEEVE, MODIFIED
K912980 · Dexide, Inc. · Jul 1991
LAPAROSCOPIC LASER FIBER DIVERTER
K912502 · United States Endoscopy Group, Inc. · Jul 1991
PAL (PROBE FOR ASPIRATION AND LAVAGE)
K911149 · Marlo Surgical Technology · Jul 1991
REICH SUCTION/IRRIGATION CANNULA
K911164 · Marlo Surgical Technology · Jul 1991
DISPOSABLE SURGICAL TROCAR WITH SEAL
K911589 · Applied Vascular Devices, Inc. · Jul 1991