Cleared Traditional

K913300 - LAPAROSTAT(TM)

K913300 is an FDA 510(k) clearance for LAPAROSTAT(TM), manufactured by Cook Ob/Gyn. The device is a Class 2 General & Plastic Surgery device with product code HAM cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K913300 · Cook Ob/Gyn · General & Plastic Surgery device
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Apr 1992
Decision
252d
Days
Class 2
Risk

K913300 is an FDA 510(k) clearance for the LAPAROSTAT(TM). Classified as Apparatus, Electrosurgical (product code HAM), Class II - Special Controls.

Submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on April 2, 1992 after a review of 252 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Ob/Gyn devices

FDA 510(k) Submission Details - K913300

510(k) Number K913300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1991
Decision Date April 02, 1992
Days to Decision 252 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
137d slower than avg
Panel avg: 115d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAM Device Classification - Class 2, Special Controls

Product Code HAM Apparatus, Electrosurgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - HAM Apparatus, Electrosurgical

All 12
Devices cleared under the same product code (HAM) and FDA review panel - the closest regulatory comparables to K913300.
Quiver Laparoscopic Extendable
K153472 · Itl Corporation Pty, Ltd. · Jun 2016
NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)
K993306 · Paladin Medical, Inc. · Nov 1999
GSU HANDPIECE ADAPTER
K920100 · Beacon Laboratories, Inc. · Feb 1992
ABC HANDPIECE ADAPTER
K901248 · Beacon Laboratories, Inc. · Apr 1990
BEAMER ONE
K894663 · Beacon Laboratories, Inc. · Sep 1989
B100 DISPOSABLE HANDPIECE
K894762 · Beacon Laboratories, Inc. · Sep 1989