Cleared Traditional

K905196 - LAPAROSCOPE

K905196 is the FDA 510(k) clearance for LAPAROSCOPE by Baxter Healthcare Corp. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K905196 · Baxter Healthcare Corp · Obstetrics & Gynecology device
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Mar 1991
Decision
104d
Days
Class 2
Risk

K905196 is an FDA 510(k) clearance for the LAPAROSCOPE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Niles, US). The FDA issued a Cleared decision on March 4, 1991 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K905196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date March 04, 1991
Days to Decision 104 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 160d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 150
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K905196.
TROCAR ACCESS SHEATH
K905471 · Cook Ob/Gyn · May 1991
PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE
K904848 · Origin Medsystems, Inc. · Apr 1991
ENDOTHRED ADJUSTABLE STABILITLY THEREAD
K910008 · Ethicon, Inc. · Mar 1991
LAPAROSCOPIC ASPIRATION PROBE
K910340 · Davol, Inc. · Feb 1991
AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE
K905426 · United States Surgical, A Division of Tyco Healthc · Feb 1991
ENDOPATH DISPOSABLE SURGICAL TROCAR REDUCER
K904907 · Ethicon, Inc. · Jan 1991