Cleared Traditional

K915298 - SUCTION/IRRIGATION CANNULA

Also marketed or referenced as:
CATLOG #532.00

K915298 is an FDA 510(k) clearance for SUCTION/IRRIGATION CANNULA, manufactured by Lifeguard Medical Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K915298 · Lifeguard Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
69d
Days
Class 2
Risk

K915298 is an FDA 510(k) clearance for the SUCTION/IRRIGATION CANNULA. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Lifeguard Medical Products, Inc. (River Forest, US). The FDA issued a Cleared decision on January 23, 1992 after a review of 69 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 Lifeguard Medical Products, Inc. devices

FDA 510(k) Submission Details - K915298

510(k) Number K915298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1991
Decision Date January 23, 1992
Days to Decision 69 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
46d faster than avg
Panel avg: 115d · This submission: 69d
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 1046
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K915298.
EVACUATION KIT #7-510-14
K914861 · Northgate Technologies, Inc. · Jan 1992
LAPAROSCOPIC SNARE POUCH
K915360 · United States Endoscopy Group, Inc. · Jan 1992
FUJINON EVL-F
K912859 · Fujinon, Inc. · Jan 1992
MARLOW LAPAROSCOPIC SCISSORS
K914869 · Marlo Surgical Technology · Jan 1992
ENDOPATH DISPOSABLE TROCAR SLEEVE W/DILATING OBTUR
K915239 · Ethicon, Inc. · Jan 1992
SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEM
K914919 · Smith & Nephew Dyonics, Inc. · Jan 1992