Cleared Traditional

K893527 - LAPAROSCOPIC SUCTION PROBE

K893527 is the FDA 510(k) clearance for LAPAROSCOPIC SUCTION PROBE by Dexide, Inc.. It is a Class 2 General Hospital device (product code JOL) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K893527 · Dexide, Inc. · General Hospital
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Jul 1989
Decision
67d
Days
Class 2
Risk

K893527 is an FDA 510(k) clearance for the LAPAROSCOPIC SUCTION PROBE. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Dexide, Inc. (Fort Worth, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 67 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - 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.

View all Dexide, Inc. devices

Submission Details

510(k) Number K893527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1989
Decision Date July 14, 1989
Days to Decision 67 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
62d faster than avg
Panel avg: 129d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOL Catheter And Tip, Suction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 Hospital devices follow this clearance model.

Regulatory Peers - JOL Catheter And Tip, Suction

All 32
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K893527.
PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET
K910693 · Baxter Healthcare Corp · Oct 1991
THOROCENTESIS KIT
K910963 · Megadyne Medical Products, Inc. · Jun 1991
CURITY THORACENTESIS TRAY
K903569 · Kendall Healthcare Products Co. Div.Of Tyco Health · Sep 1990
ARROW PNEUMOTHORAX KIT, AK-01500
K883905 · Arrow Intl., Inc. · Jan 1989
URESIL THORA-FLO THORACENTESIS PROCEDURE KIT
K872948 · Uresil Corp. · Nov 1987
DEKNATEL THORACIC CATHETER
K873517 · Deknatel, Inc. · Nov 1987