Cleared Traditional

K923201 - ENDOSI SUCTION IRRIGATOR

K923201 is an FDA 510(k) clearance for ENDOSI SUCTION IRRIGATOR, manufactured by Armm, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 450-day FDA review.

K923201 · Armm, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
450d
Days
Class 2
Risk

K923201 is an FDA 510(k) clearance for the ENDOSI SUCTION IRRIGATOR. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Armm, Inc. (Huntington Beach, US). The FDA issued a Cleared decision on September 23, 1993 after a review of 450 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Armm, Inc. devices

FDA 510(k) Submission Details - K923201

510(k) Number K923201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1992
Decision Date September 23, 1993
Days to Decision 450 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
335d slower than avg
Panel avg: 115d · This submission: 450d
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 724
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K923201.
DISTENTION INSTRUMENT, MODIFICATION
K934134 · Origin Medsystems, Inc. · Oct 1993
PROCEDURE KITS
K933160 · Ethicon Endo-Surgery, Inc. · Oct 1993
AUTO SUTURE ENDOSCOPIC INSTRUMENT CLAMP
K932885 · United States Surgical, A Division of Tyco Healthc · Sep 1993
SURGICAL TROCAR AND CANNULA
K932995 · Applied Medical Resources · Sep 1993
ONE-HANDED ENDOPOUCH SPECIMEN RETRIEVAL BAG
K933104 · Ethicon, Inc. · Sep 1993
AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS
K933076 · Aesculap, Inc. · Sep 1993