Cleared Traditional

K922418 - VIDEO ENDOSCOPE SYSTEM

K922418 is an FDA 510(k) clearance for VIDEO ENDOSCOPE SYSTEM, manufactured by Baxter Healthcare Corp. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 434-day FDA review.

K922418 · Baxter Healthcare Corp · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
434d
Days
Class 2
Risk

K922418 is an FDA 510(k) clearance for the VIDEO ENDOSCOPE SYSTEM. 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 July 29, 1993 after a review of 434 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Obstetrics & Gynecology submissions.

FDA 510(k) Submission Details - K922418

510(k) Number K922418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1992
Decision Date July 29, 1993
Days to Decision 434 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
273d slower than avg
Panel avg: 161d · This submission: 434d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

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 337
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K922418.
URESIL LAPAROSCOPIC RETRACTOR
K921417 · Uresil Corp. · Oct 1993
MALLAWANY TISSUE GRASPING FORCEPS
K923126 · Numed Technologies, Inc. · Oct 1993
BULK TISSUE REMOVAL SYSTEM
K924844 · L.A.S.E.R., Inc. · Oct 1993
SHARPE ENDOSPONGE ASPIIRATOR
K921015 · Paladin Medical, Inc. · May 1993
SHARPE ENDOTENACULUM
K915743 · Paladin Medical, Inc. · May 1993
DAVOL LAPAROSCOPIC DISSECTORS
K920234 · C.R. Bard, Inc. · Feb 1993
K922418 · VIDEO ENDOSCOPE SYSTEM
Download PDF FDA Summary Baxter Healthcare Corp